- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05364073
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Nichole Baio
- Phone Number: 628-277-4836
- Email: FURMO002CT@arrivent.com
Study Locations
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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St Leonards, New South Wales, Australia, 2065
- Recruiting
- ArriVent Investigative Site
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Contact:
- ArriVent I Site
- Email: FURMO002ct@arrivent.com
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Edmonton, Canada, T6G 1Z2
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Toronto, Canada, M5G 2M9
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Anhui
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Hefei, Anhui, China, 230001
- Recruiting
- Allist Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Beijing
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Beijing, Beijing, China, 101119
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Chaoyang, Beijing, China, 100021
- Recruiting
- Allist Investigative Site
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Contact:
- ArriVent I Site
- Email: FURMO002ct@arrivent.com
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Haidan, Beijing, China, 100142
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Chongqing
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Chongqing, Chongqing, China, 400030
- Recruiting
- Allist Investigative Site
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Contact:
- ArriVent I Site
- Email: FURMO002ct@arrivent.com
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Guizhou
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Guiyang, Guizhou, China, 550004
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Heilongjiang
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Harbin, Heilongjiang, China, 150081
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Henan
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Zhengzhou, Henan, China, 450052
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Zhengzhou, Henan, China, 450003
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Hubei
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Wuhan, Hubei, China, 430022
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Jiangsu
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XuZhou, Jiangsu, China, 221000
- Recruiting
- Allist Investigative Site
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Contact:
- ArriVent I Site
- Email: FURMO002ct@arrivent.com
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Jianxi
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Nanchang, Jianxi, China, 330008
- Recruiting
- Allist Investigative Site
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Contact:
- Allist i Site
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Jilin
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Changchun, Jilin, China, 130012
- Recruiting
- Allist Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Contact:
- Allist i Site
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Shan Dong
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Jinan, Shan Dong, China, 250021
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Shandong
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Jinan, Shandong, China, 250117
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Shanghai
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Shanghai, Shanghai, China, 200030
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Shanxi
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Taiyuan, Shanxi, China, 030013
- Recruiting
- Allist Investigative Site
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Contact:
- Allist I Site
- Email: FURMO002CT@arrivent.com
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Lyon, France, 69373
- Recruiting
- ArriVent Investigative Site
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Contact:
- ArriVent I Site
- Email: FURMO002ct@arrivent.com
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Toulouse, France, 31059
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Villejuif, France, 94800
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Medolla, Italy, 47014
- Not yet recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Milano, Italy, 20141
- Not yet recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Chiba
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Chiba-Shi, Chiba, Japan, 260-0013
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Osaka
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Ōsaka-sayama, Osaka, Japan, 589-8511
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Tokyo
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Chuo, Tokyo, Japan, 104-0045
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Koto-Ku, Tokyo, Japan, 135-8550
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Gwangju, Korea, Republic of, 61469
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Seoul, Korea, Republic of, 2447
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1066 CX
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Barcelona, Spain, 08035
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Madrid, Spain, 28033
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Madrid, Spain, 28050
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Valencia, Spain, 46026
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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London, United Kingdom, NW12PG
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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London, United Kingdom, SW36JJ
- Not yet recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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California
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Sacramento, California, United States, 95817
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Florida
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Celebration, Florida, United States, 34747
- Recruiting
- ArriVent Investigative Site
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Contact:
- ArriVent I Site
- Email: FURMO002ct@arrivent.com
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Michigan
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Detroit, Michigan, United States, 48202
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- ArriVent Investigative Site
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Contact:
- Email: FURMO002CT@arrivent.com
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Virginia
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Fairfax, Virginia, United States, 22031
- Recruiting
- ArriVent Investigative Site
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Contact:
- Carrie Friedman
- Phone Number: 703-636-1473
- Email: Carrie.Friedman@usoncology.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- Disease that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable; or for whom a clinical trial of an investigational agent is a recognized standard of care.
- Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of furmonertinib.
- For patients with Epidermal Growth Factor Receptor (EGFR) mutations sensitive to osimertinib, the patient must have received osimertinib prior to study enrollment in regions where osimertinib is approved, including the US.
Stage 1 dose escalation and backfill cohorts and Stage 2 Cohorts 1, 2, 3 and 4:
-Patients with CNS metastases (including leptomeningeal disease) may be eligible if meeting additional protocol specified criteria.
Stage 1 Dose Escalation and Backfill Cohorts Inclusion Criteria:
- Documented validated results from local testing of tumor tissue or blood confirming the presence of an activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory.
Stage 2 Cohort 1 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Exon 20 Insertion Mutations Inclusion Criteria
- Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.
- The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
Stage 2 Cohort 2 Previously treated, Locally Advanced or Metastatic NSCLC Patients with HER2 Exon 20 Insertion Mutations Inclusion Criteria
- Documented validated results from local testing of either tumor tissue or blood confirming the presence of HER2 Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.
- The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
- In regions in which fam-trastuzumab deruxtecan-nxki is approved and available for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 exon 20 mutations, the patient must have received or be considered not appropriate to receive fam-trastuzumab deruxtecan-nxki.
Stage 2 Cohort 3 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Activating Mutations Mutations, who are not eligible for Cohorts 1 and 4 Inclusion Criteria
- Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR activating mutation, performed at a CLIA- or equivalently certified laboratory.
- The patient must have experienced disease progression or have intolerance to treatment with the standard of care EGFR TKI.
- Patients with CNS metastases may be eligible if meeting additional protocol specified criteria.
Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations excluding EGFR Exon 20 insertions Inclusion Criteria
- Previously untreated in the locally advanced or metastatic setting or have progressed after at least 1 available standard therapy, or for whom standard therapy has proven to be ineffective, intolerable, or considered inappropriate
- Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR Uncommon mutation, performed at a CLIA- or equivalently certified laboratory a. Representative mutations include, but are not limited to, G719X, S768I, E709X, G779F, L747X, V774M, E709_T710delinsD, R776C/H, G724S, E736K, I740_K745dup, N771G, K757M/R, V769L/M, T854X, T751_I759delinsN
Key Exclusion Criteria:
- Treatment with chemotherapy, targeted therapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 or 3 elimination weeks or five half-lives prior to initiation of furmonertinib, whichever is shorter, or endocrine therapy within 2 weeks prior to initiation of furmonertinib.
- Radiation therapy as cancer therapy within 4 weeks prior to initiation of furmonertinib.
- Palliative radiation to bone metastases within 2 weeks prior to initiation of furmonertinib.
- AE from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy.
Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations Exclusion Criteria
- Prior treatment with any EGFR TKIs
- Progression during neoadjuvant or adjuvant therapy (e.g., chemotherapy, radiotherapy, immunotherapy or investigational agents) or within 12 months of completion of above therapies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stage 2 Expansion Cohort 1
Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations
|
Furmonertinib tablet
Other Names:
|
Experimental: Stage 2 Expansion Cohort 2
Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations
|
Furmonertinib tablet
Other Names:
|
Experimental: Stage 1 Dose Escalation and Backfill
Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations
|
Furmonertinib tablet
Other Names:
|
Experimental: Stage 2 Expansion Cohort 3
Previously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4
|
Furmonertinib tablet
Other Names:
|
Experimental: Stage 2 Expansion Cohort 4
Untreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations
|
Furmonertinib tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Time Frame: Up to 36 months after first dose
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Up to 36 months after first dose
|
Stage 2: Overall Response Rate (ORR)
Time Frame: Up to 36 months after first dose
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Up to 36 months after first dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stage 1: Overall Response Rate
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 1: Duration of Response (DOR)
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 1: Disease Control Rate
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 1: Progression Free Survival
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 1: Depth of Response
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 1: Overall survival
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 1: Central Nervous System ORR
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 1: Central Nervous System DOR
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 1: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time Frame: Up to 36 months after first dose
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Up to 36 months after first dose
|
Stage 1, Cohort 1, Backfill only: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time Frame: Up to 36 months after first dose
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Up to 36 months after first dose
|
Stage 1, Cohort 1, Backfill only: Plasma concentrations of midazolam and its metabolite (1-OH-midazolam)
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Duration of Response
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Disease Control Rate
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Progression Free Survival
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Depth of Response
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Overall survival
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Central Nervous System ORR
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Central Nervous System DOR
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, Cohort 4 only: Overall Response Rate
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Number of incidence and severity of AEs as a measure of safety and tolerability of Furmonertinib
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Stage 2, all cohorts: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time Frame: Up to 36 months after first dose
|
Up to 36 months after first dose
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Morgan Lam, ArriVent BioPharma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- HER2
- Tyrosine Kinase Inhibitor (TKI)
- EGFR
- Non-small cell lung cancer (NSCLC)
- osimertinib
- Metastatic Non-Small Cell Lung Cancer
- afatinib
- Exon 20
- Advanced Non-Small Cell Lung Cancer
- Epidermal Growth Factor Receptor (EGFR)
- Exon 20 Insertion Mutations
- HER2 kinase domain mutations
- HER2 Exon 20 Insertion Mutations
- EGFR uncommon mutations
- EGFR atypical mutations
- G719X
- S768I
- E709X
- E709_T710del insD
- G779F
- L747X
- V774M
- Human Epidermal Growth Factor Receptor 2 (HER2)
- Epidermal Growth Factor Receptor (EGFR) kinase domain mutations
- Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations
- EGFR rare mutations
- R776C/H
- G724S
- E736K
- I740_K745dup
- N771G
- K757M/R
- V769L/M
- T854X
- T751_I759delinsN
- G719A
- G719S
- R776C
- R776H
- K757M
- K757R
- V769L
- V769M
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Aflutinib
Other Study ID Numbers
- FURMO-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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