Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment (SAFFRON)

A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma; Non-Small-Cell Lung
• Intervention / Treatment: Drug: Pemetrexed; Drug: Carboplatin; Drug: Savolitinib; Drug: Osimertinib; Drug: Cisplatin

Detailed Description

This is a multicentre, Phase III, randomised, open-label study to investigate the efficacy and safety of savolitinib administered orally in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with osimertinib as the most recent therapy.

Approximately 324 participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC will be randomly assigned to study intervention with 1:1 ratio.

Patients will be treated until either objective progression of disease (PD) by Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn, or another discontinuation criterion is met.

• Study Type: Interventional
• Enrollment (Actual): 345
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Research Site
  • CABA, Argentina, C1019ABS
    • Research Site
  • Florida, Argentina, B1602DQD
    • Research Site
  • La Rioja, Argentina, F5300COE
    • Research Site
  • Rosario, Argentina, 2000
    • Research Site
  • Rosario, Argentina, 2123
    • Research Site
  • San Miguel de Tucumán, Argentina, 4000
    • Research Site
  • Viedma, Argentina, R8500ACE
    • Research Site
• Australia
  • Clayton, Australia, 3168
    • Research Site
  • Fremantle, Australia, 6160
    • Research Site
  • Liverpool, Australia, 2170
    • Research Site
  • Southport, Australia, 4215
    • Research Site
  • Waratah NSW, Australia, 2298
    • Research Site
  • Westmead, Australia, 2145
    • Research Site
• Austria
  • Salzburg, Austria, 5020
    • Research Site
• Belgium
  • Brussels, Belgium, 1000
    • Research Site
  • Edegem, Belgium, B-2650
    • Research Site
  • Ghent, Belgium, 9000
    • Research Site
  • Hasselt, Belgium, 3500
    • Research Site
  • Mons, Belgium, 7000
    • Research Site
  • Roeselare, Belgium, 8800
    • Research Site
  • Sint-Niklaas, Belgium, 9100
    • Research Site
• Brazil
  • Belo Horizonte, Brazil, 30110-022
    • Research Site
  • Brasília, Brazil, 70390-700
    • Research Site
  • Cachoeiro de Itapemirim, Brazil, 29308-014
    • Research Site
  • Curitiba, Brazil, 80810-050
    • Research Site
  • Ijuí, Brazil, 98700-000
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Research Site
  • Porto Alegre, Brazil, 90050-170
    • Research Site
  • Porto Alegre, Brazil, 90540-140
    • Research Site
  • Rio de Janeiro, Brazil, 22793-080
    • Research Site
  • Rio de Janeiro, Brazil, 22281-100
    • Research Site
  • Salvador, Brazil, 41253-190
    • Research Site
  • Salvador, Brazil, 41950-610
    • Research Site
  • São Paulo, Brazil, 04538-132
    • Research Site
  • São Paulo, Brazil, 04556-100
    • Research Site
  • Vitória, Brazil, 29043-260
    • Research Site
• Bulgaria
  • Pleven, Bulgaria, 5804
    • Research Site
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
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  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Research Site
    • Montreal, Quebec, Canada, H3T 1M5
      • Research Site
• Chile
  • Santiago, Chile, 7500713
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• China
  • Baoding, China, 71030
    • Research Site
  • Beijing, China, 101149
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  • Beijing, China, 100036
    • Research Site
  • Bengbu, China, 233004
    • Research Site
  • Changchun, China, 130012
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  • Changsha, China, 410011
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  • Changsha, China, 41003
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  • Chengdu, China, 610041
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  • Chongqing, China, 400016
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  • Fuzhou, China, 350011
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  • Fuzhou, China, 350001
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  • Hangzhou, China, 310022
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  • Harbin, China, 150040
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  • Hefei, China, 230031
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  • Jinan, China, 250022
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  • Linyi, China, 276000
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  • Nanchang, China, 330006
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  • Qingdao, China, 266035
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  • Shanghai, China, 200030
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  • Shenyang, China, 110001
    • Research Site
  • Shenzhen, China, 518020
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  • Wuhan, China, 430079
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  • Wuhan, China, 430022
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  • Xi'an, China, 710061
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  • Xi'an, China, 710100
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  • Xiangfan, China, 441021
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  • Yichang, China, 443003
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  • Zhengzhou, China, 450008
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• France
  • Bobigny, France, 93000
    • Research Site
  • Brest, France, 29200
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  • Créteil, France, 94010
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  • Dijon, France, 21079
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  • Marseille, France, 13915
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  • Paris, France, 75005
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  • Poitiers, France, 86021
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  • Rennes, France, 35033
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  • Rouen, France, 76000
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  • Saint-Herblain, France, 44800
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  • Saint-Quentin, France, 02321
    • Research Site
  • Strasbourg, France, 67091
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  • Suresnes, France, 92151
    • Research Site
• Germany
  • Berlin, Germany, 14165
    • Research Site
  • Chemnitz, Germany, 09113
    • Research Site
  • Frankfurt A. Main, Germany, 60590
    • Research Site
  • Gauting, Germany, 82131
    • Research Site
  • Immenhausen, Germany, 34376
    • Research Site
  • Löwenstein, Germany, 74245
    • Research Site
  • München, Germany, 81925
    • Research Site
  • Münster, Germany, 48149
    • Research Site
  • Wangen, Germany, 88239
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 115 27
    • Research Site
  • Chaïdári, Greece, 124 62
    • Research Site
  • Heraklion, Greece, 71110
    • Research Site
  • Larissa, Greece, 41110
    • Research Site
  • Rio, Greece, 265 04
    • Research Site
  • Thessaloniki, Greece, 54622
    • Research Site
  • Thessaloniki, Greece, 546 39
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Research Site
  • Kowloon, Hong Kong
    • Research Site
• Israel
  • Afula, Israel, 18341
    • Research Site
  • Ashdod, Israel, 7747629
    • Research Site
  • Be’er Ya‘aqov, Israel, 70300
    • Research Site
  • Hadera, Israel, 38100
    • Research Site
  • Jerusalem, Israel, 91031
    • Research Site
  • Tel Aviv, Israel, 6423906
    • Research Site
• Italy
  • Avellino, Italy, 83100
    • Research Site
  • Aviano, Italy, 33081
    • Research Site
  • Catania, Italy, 95123
    • Research Site
  • Meldola, Italy, 47014
    • Research Site
  • Milan, Italy, 20141
    • Research Site
  • Milan, Italy, 20133
    • Research Site
  • Modena, Italy, 41124
    • Research Site
  • Monserrato, Italy, 09042
    • Research Site
  • Naples, Italy, 80138
    • Research Site
  • Orbassano, Italy, 10043
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Parma, Italy, 43126
    • Research Site
  • Perugia, Italy, 6124
    • Research Site
  • Peschiera del Garda, Italy, 37019
    • Research Site
  • Roma, Italy, 00152
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  • Roma, Italy, 00144
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  • Treviso, Italy, 31100
    • Research Site
• Japan
  • Bunkyō City, Japan, 113-8603
    • Research Site
  • Chūōku, Japan, 104-0045
    • Research Site
  • Fukuoka, Japan, 812-8582
    • Research Site
  • Hirosaki-shi, Japan, 036-8563
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  • Hiroshima, Japan, 730-8518
    • Research Site
  • Iwakuni-shi, Japan, 740-8510
    • Research Site
  • Kanazawa, Japan, 920-8641
    • Research Site
  • Kashiwa, Japan, 277-8577
    • Research Site
  • Kobe, Japan, 650-0046
    • Research Site
  • Kobe, Japan, 650-0017
    • Research Site
  • Kumamoto, Japan, 860-8556
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Research Site
  • Nagasaki, Japan, 852-8501
    • Research Site
  • Okayama, Japan, 700-8558
    • Research Site
  • Osaka, Japan, 534-0021
    • Research Site
  • Osakasayama-shi, Japan, 589-8511
    • Research Site
  • Sakaishi, Japan, 591-8555
    • Research Site
  • Sapporo, Japan, 003-0804
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  • Sapporo, Japan, 060-8638
    • Research Site
  • Sendai, Japan, 980-0873
    • Research Site
  • Sunto-gun, Japan, 411-8777
    • Research Site
  • Utsunomiya, Japan, 320-0834
    • Research Site
  • Wakayama, Japan, 641-8510
    • Research Site
  • Yokohama, Japan, 241-8515
    • Research Site
• Malaysia
  • Kota Bharu, Malaysia, 15586
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Research Site
  • Petaling Jaya, Malaysia, 47500
    • Research Site
  • Pulau Pinang, Malaysia, 10990
    • Research Site
  • Sabak Bernam, Malaysia, 88996
    • Research Site
• Philippines
  • Bacolod, Philippines, 6100
    • Research Site
  • Davao City, Philippines, 8000
    • Research Site
  • Manila, Philippines, 1000
    • Research Site
  • Quezon City, Philippines, 1112
    • Research Site
  • Quezon City, Philippines, 1100
    • Research Site
  • San Juan City, Philippines, 1502
    • Research Site
• Poland
  • Lodz, Poland, 93-338
    • Research Site
  • Olsztyn, Poland, 10-357
    • Research Site
• Singapore
  • Singapore, Singapore, 169610
    • Research Site
  • Singapore, Singapore, 308433
    • Research Site
• South Korea
  • Goyang-si, South Korea, 10408
    • Research Site
  • Gyeonggi-do, South Korea, 13620
    • Research Site
  • Jinju, South Korea, 660-702
    • Research Site
  • Seoul, South Korea, 08308
    • Research Site
  • Seoul, South Korea, 06273
    • Research Site
  • Seoul, South Korea, 06351
    • Research Site
  • Seoul, South Korea, 138-736
    • Research Site
  • Seoul, South Korea, 6591
    • Research Site
  • Suwon, South Korea, 16247
    • Research Site
• Spain
  • Badajoz, Spain, 6006
    • Research Site
  • Badalona, Spain, 8916
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 8035
    • Research Site
  • Córdoba, Spain, 14004
    • Research Site
  • Girona, Spain, 17007
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Majadahonda, Spain, 28222
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Pontevedra, Spain, 36312
    • Research Site
  • Sabadell, Spain, 08208
    • Research Site
  • Seville, Spain, 41009
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site
• Switzerland
  • Baden, Switzerland, CH-5405
    • Research Site
  • Zurich, Switzerland, 8063
    • Research Site
• Taiwan
  • Chiayi City, Taiwan, 62247
    • Research Site
  • Hsinchu, Taiwan, 300
    • Research Site
  • Kaohsiung City, Taiwan, 83301
    • Research Site
  • Liuying, Taiwan, 736
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 404
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
  • Taipei, Taiwan
    • Research Site
  • Taipei, Taiwan, 11259
    • Research Site
• Thailand
  • Bangkok, Thailand, 10210
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Chanthaburi, Thailand, 22000
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Research Site
  • Dusit, Thailand, 10300
    • Research Site
  • Hat Yai, Thailand, 90110
    • Research Site
  • Muang, Thailand, 40002
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1370
    • Research Site
  • Ankara, Turkey (Türkiye), 6800
    • Research Site
  • Edirne, Turkey (Türkiye), 22030
    • Research Site
  • Istanbul, Turkey (Türkiye), 34722
    • Research Site
  • Istanbul, Turkey (Türkiye), 34214
    • Research Site
  • Izmir, Turkey (Türkiye), 35100
    • Research Site
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Research Site
  • Wolverhampton, United Kingdom, WV10 0QP
    • Research Site
• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Research Site
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Research Site
  • New York
    • New York, New York, United States, 10032
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Research Site
• Vietnam
  • Can Tho, Vietnam, 900000
    • Research Site
  • Hanoi, Vietnam, 100000
    • Research Site
  • Hanoi, Vietnam, 10000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.
• Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted.
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.
• Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
• Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.
• Mandatory provision of FFPE tumour tissue.
• MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
• Measurable disease as defined by RECIST 1.1.
• Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
• ECOG performance status of 0 or 1.

Exclusion Criteria:

• Predominant squamous NSCLC, and small cell lung cancer.
• Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
• Prior or current treatment with savolitinib or another MET inhibitors.
• Spinal cord compression or brain metastases, unless asymptomatic and are stable.
• History or active leptomeningeal carcinomatosis.
• Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL.
• Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals.
• History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement.
• Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease.
• Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention.
• Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD.
• Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chemotherapy; Pemetrexed (500 mg/m2) with either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles (Q3W) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) Q3W	Drug: Pemetrexed; Pemetrexed (500 mg/m2) Administrative route : IV infusion; Other Names: NAP; Drug: Carboplatin; Carboplatin (AUC5) Administrative route : IV infusion; Other Names: NAP; Drug: Cisplatin; Cisplatin (75 mg/m2) Administrative route : IV infusion; Other Names: NAP
Experimental: Savolitinib + Osimertinib; 300 mg savolitinib BID plus 80 mg osimertinib QD	Drug: Savolitinib; 300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral; Other Names: AZD6094, HMPL-504, volitinib; Drug: Osimertinib; 80 mg osimertinib (1 × 80 mg tablet once daily) Administrative route : oral; Other Names: AZD9291, Tagrisso

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib.	Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.	Approximately 36.5 months post first subject randomized

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.	Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.	Approximately 55 months post first subject randomized
Overall Survival (OS) / savolitinib in combination with osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed by IHC, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.	Defined as time from randomisation until the date of death due to any cause.	Approximately 55 months post first subject randomized
Objective response rate (ORR) savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.	ORR defined as the proportion of participants who have BOR of a CR or PR, as determined by BICR per RECIST 1.1.	Approximately 55 months post first subject randomized
Participant-reported pulmonary core symptoms / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib.	TTD in pulmonary core symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ. TTD is defined as the time from randomisation until the date of deterioration.	Approximately 55 months post first subject randomized
Disease control rate (DCR) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.	DCR defined as the proportion of participants who have BOR of a CR, PR, or stable disease, as determined by BICR per RECIST 1.1.	Approximately 55 months post first subject randomized
Time to discontinuation of treatment (TDT) or death / savolitinib + osimertinib vs platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on osimertinib	TDT or death is defined as the time from date of randomisation to the earlier of the date of study intervention discontinuation or death.	Approximately 55 months post first subject randomized
Tumor shrinkage / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.	Tumour shrinkage defined as percentage change in tumour size in accordance with RECIST 1.1.	Approximately 55 months post first subject randomized
Duration of response (DoR) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.	DoR defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR, or death in the absence of disease progression.	Approximately 55 months post first subject randomized
Overall Survival (OS) /savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.	Defined as time from randomisation until the date of death due to any cause.	Approximately 36.5+18 months post first subject randomized.
Savolitinib+osimertinib vs platinum doublet chemotherapy in terms of BICR-assessed CNS endpoints in participants with EGFR mutated, MET overexpressed and/or amplified, locally advanced or metastatic NSCLC progressed on treatment with osimertinib	CNS PFS, defined as the time from randomisation until the date of CNS progression assessed per CNS modified RECIST v1.1 by BICR or death.	Approximately 55 months post first subject randomized
Savolitinib+osimertinib vs platinum doublet chemotherapy in terms of BICR-assessed CNS endpoints in participants with EGFR mutated, MET overexpressed and/or amplified, locally advanced or metastatic NSCLC progressed on treatment with osimertinib	CNS ORR defined as the proportion of participants who have a BOR in the CNS by BICR assessment.	Approximately 55 months post first subject randomized
Savolitinib+osimertinib vs platinum doublet chemotherapy in terms of BICR-assessed CNS endpoints in participants with EGFR mutated, MET overexpressed and/or amplified, locally advanced or metastatic NSCLC progressed on treatment with osimertinib	CNS DoR defined as the time from the date of first documented response in the CNS until the date of objective CNS progression as assessed by BICR or death in the absence of disease progression.	Approximately 55 months post first subject randomized
Pharmacokinetics (PK) of savolitinib.	Plasma concentrations of savolitinib and its metabolites.	Approximately 36.5 months post first subject randomized

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Shun Lu, Prof,MD,PhD,, Shanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.

Publications and helpful links

Helpful Links

• Lung Cancer Study Locator details (for US)

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): November 23, 2026

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: carcinoma; NSCLC; EGFR; Metastatic; Osimertinib; Savolitinib; Amplified; MET Driven; overexpressed
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasm Metastasis; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Pemetrexed; Carboplatin; Cisplatin; osimertinib; 1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine
• Other Study ID Numbers: D5087C00001; 2021-006374-24 (EudraCT Number); 2024-511169-12-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No