ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003)

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

Study Overview

• Status: Active, not recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Gotistobart

Detailed Description

This is a seamless 2-stage, randomized, open-label, active-controlled, Phase 3 study. The study population consists of patients with NSCLC who progressed on PD-1/PD-L1 inhibitor. Approximately 630 patients will be enrolled.

Two gotistobart dosing regimens will be tested in Stage I, and one will be selected for Stage II.

Stage I, the dose-confirmation stage, will assess the efficacy and safety of two gotistobart dosing regimens (3 mg/kg Q3W and 6 mg/kg Q3W with 2 loading doses of 10 mg/kg Q3W) in comparison to docetaxel 75 mg/m2 Q3W.

Stage II will assess the safety and efficacy of gotistobart at the selected dosing regimen versus docetaxel on squamous cell NSCLC. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.

• Study Type: Interventional
• Enrollment (Estimated): 630
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
      • Bankstown Hospital - 3305
  • Queensland
    • Newstead, Queensland, Australia, 4006
      • Mater - 3301
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Cancer Research SA - 3303
  • Victoria
    • St Albans, Victoria, Australia, 3021
      • Western Health - Sunshine Hospital - 3307
• Belgium
  • Ghent, Belgium, 9000
    • AZ Maria Middelares - 2104
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
  • Liège, Belgium, 4000
    • C. H. R. de la Citadelle - 2103
  • Sint-Niklaas, Belgium, 9100
    • Vitaz - Sint-niklaas Moerland - 2101
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada
      • BC Cancer Centre - Kelowna - 1203
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Saskatchewan Cancer Agency - Regina - 1201
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202
• China
  • Beijing, China, 100029
    • China-Japan Friendship Hospital - 3236
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University - 3238
  • Jiangse, China, 21006
    • Nanjing Medical University (NMU) - Nanjing First Hospital - 3239
  • Shandong, China, 261041
    • Weifang Second People's Hospital - 3235
  • Shanghai, China, 200120
    • Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240
  • Wuhan, China, 430079
    • Hubei Cancer Hospital - 3237
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University - 3221
    • Hefei, Anhui, China, 231200
      • Anhui Medical University - The Second Hospital - 3222
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Cancer Hospital - 3205
    • Beijing, Beijing Municipality, China
      • Cancer Hospital, Chinese Academy of Medical Sciences - 3211
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Medical University Union Hospital - 3225
    • Xiamen, Fujian, China
      • The First Affiliated Hospital of Xiamen University - 3210
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan People's Hospital - 3206
    • Guangzhou, Guangdong, China, 510105
      • Guangdong Provincial People's Hospital - 3201
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University - 3203
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The People's Hospital of Guangxi Zhuang Autonomous Region - 3228
  • Hainan
    • Haikou, Hainan, China
      • Hainan General Hospital - 3202
  • Hebei
    • Zhengzhou, Hebei, China, 71000
      • Affiliated Hospital of Hebei University - 3214
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • The Affiliated Tumor Hospital of Harbin Medical University - 3232
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital - 3226
    • Zhengzhou, Henan, China
      • The First Affliated Hospital of Zhengzhou University - 3207
  • Hubei
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University - 3216
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College - 3212
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital, Central South University - 3223
    • Changsha, Hunan, China
      • Hunan Cancer Hospital - 3209
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The Second Affiliated Hospital of Soochow University - 3217
    • Xuzhou, Jiangsu, China, 221002
      • Xuzhou Medical University - The Affiliated Hospital - 3234
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University - 3224
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital - 3230
  • Shanxi
    • Taiyuan, Shanxi, China, 30032
      • Shanxi Bethune Hospital - 3233
    • Xi’an, Shanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University - 3218
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Chengdu Seventh People's Hospital - 3229
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital - 3227
    • Chongqing, Sichuan, China
      • Chongqing University Cancer Hospital - 3213
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Medical University Cancer Institute and Hospital - 3208
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital - 3231
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital - 3204
• Germany
  • Bogenhausen, Germany, 81925
    • Städt. Klinikum München GmbH - 2204
  • Essen, Germany, 45136
    • Kliniken Essen-Mitte - 2206
  • Esslingen am Neckar, Germany, 73730
    • Klinikum Esslingen GmbH - 2201
  • Immenhausen, Germany, 34376
    • Lungenfachklinik Immenhausen - 2202
  • Immenstädt, Germany, 87509
    • Klinikverbund Allgaü - Klinikum Kempten - 2205
  • Muenchen-Gauting, Germany, 82131
    • Asklepios Fachkliniken Muenchen-Gauting - 2203
• Italy
  • Ancona, Italy, 60126
    • Clinica Oncologica Ospedali Riuniti Ancona - 2311
  • Bari, Italy, 70124
    • IRCCS Istituto Tumori Giovanni Paolo II - 2306
  • Bergamo, Italy, 24126
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310
  • Catania, Italy, 95045
    • Humanitas Istituto Clinico Catanese - 2312
  • Milan, Italy, 20132
    • Ospedale San Raffaele - 2307
  • Milan, Italy, 20133
    • Fondazione IRCCS Instituto Tumori Di Milano - 2305
  • Monza, Italy, 20900
    • Ospedale San Gerardo di Monza - 2302
  • Naples, Italy, 80131
    • Azienda Ospedaliera Universitaria "Federico II" - 2304
  • Palermo, Italy, 90129
    • AOU Policlinico Giaccone, Università di Palermo - 2309
  • Perugia, Italy, 06132
    • Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308
  • Roma, Italy, 00128
    • Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303
• Netherlands
  • Amsterdam, Netherlands, 1066 CV
    • Antoni van Leeuwenhoek - 2703
  • Arnhem, Netherlands, 6815
    • Rijnstate Ziekenhuis - 2701
  • Tilburg, Netherlands, 5022 GC
    • ETZ Elisabeth - 2704
• South Korea
  • Cheongju-si, South Korea, 28644
    • Chungbuk National University Hospital - 3101
  • Daegu, South Korea, 42601
    • Keimyung University Dongsan Hospital - 3102
  • Goyang-si, South Korea, 10408
    • National Cancer Center - 3107
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System - 3104
  • Seoul, South Korea, 05505
    • Asan Medical Centre - 3103
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital - 3106
  • Suwon, South Korea, 16247
    • The Catholic University of Korea, St Vincent's Hospital - 3105
• Spain
  • Elche, Spain, 03203
    • Hospital General Universitario de Elche - 2401
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti - 2405
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon - 2404
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga - 2403
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia - 2406
  • Valencia, Spain, 56009
    • Fundacion Instituto Valenciano De Oncologia (IVO) - 2402
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • Adana Sehir Hastanesi - 2602
  • Adana, Turkey (Türkiye)
    • Baskent University Adana - 2601
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universitesi - 2609
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Sehir Hastanesi - 2610
  • Antalya, Turkey (Türkiye)
    • Akdeniz University Medical Hospital - 2606
  • Edirne, Turkey (Türkiye)
    • Trakya University Faculty of Medicine Edirne - 2608
  • Fatih, Turkey (Türkiye), 34093
    • Istanbul Üniversitesi Onkoloji Enstitüsü - 2613
  • Istanbul, Turkey (Türkiye), 34010
    • Koc Universitesi - 2611
  • Istanbul, Turkey (Türkiye)
    • Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
  • Istanbul, Turkey (Türkiye)
    • Istanbul Bakirkoy Sadi Konuk - 2604
  • Istanbul, Turkey (Türkiye)
    • Medipol University Medical Faculty Hospital - 2603
  • Izmir, Turkey (Türkiye)
    • Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College London Hospital - 2811
  • England
    • Birmingham, England, United Kingdom, B15 2TG
      • University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
    • Cambridge, England, United Kingdom, CB2 0QQ
      • Cambridge University Hospitals - 2804
    • Exeter, England, United Kingdom, EX25DW
      • Royal Devon University Healthcare NHS - 2808
    • Leicester, England, United Kingdom, LE1 5WW
      • University Hospital Leicester - 2806
    • London, England, United Kingdom, EC1A 7BE
      • Barts Health NHS Trust (St. Bartholomew's Hospital) - 2803
    • Middlesbrough, England, United Kingdom, TS4 3BW
      • South Tees Hospitals - 2807
    • Torquay, England, United Kingdom, TQ2 7AA
      • Torbay and South Devon NHS Foundation Trust - 2805
  • London
    • Manchester, London, United Kingdom, M20 4BX
      • The Christie NHS Foundation Trust - 2802
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH54 6PP
      • Edinburgh Cancer Centre - 2809
• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • XCancer/Dothan Hematology & Oncology - 1114
  • Arkansas
    • Russellville, Arkansas, United States, 72801
      • Genesis Cancer and Blood Institute - 1123
  • California
    • Cerritos, California, United States, 90703
      • The Oncology Institute (TOI) Clinical Research - 1109
    • Redlands, California, United States, 92373
      • Emad Ibrahim MD Inc. - 1147
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center - 1103
    • Walnut Creek, California, United States, 94598
      • Bass Medical Group - 1155
  • Connecticut
    • Norwalk, Connecticut, United States, 06850
      • Nuvance Health - 1118
  • Florida
    • Margate, Florida, United States, 33063
      • D&H Cancer Research Center LLC - 1153
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center PL - 1102
    • Orlando, Florida, United States, 32804
      • AdventHealth Cancer Institute - 1105
    • Orlando, Florida, United States, 32806
      • Orlando Health - 1130
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialists -South - 1126
    • The Villages, Florida, United States, 32159
      • Florida Cancer Specialists -North - 1125
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists -East - 1124
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research, Inc. - 1116
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic - The Cancer Center - 1110
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Fort Wayne Medical Oncology - 1133
    • Newburgh, Indiana, United States, 47630
      • Deaconess Chancellor Center for Oncology - 1131
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center - 1151
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky - Markey Cancer Center - 1112
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute - 1108
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Jefferson City Medical Group - 1145
    • Kansas City, Missouri, United States, 64132
      • MidAmerica Cancer Care - 1163
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Astera Cancer Care - 1128
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center - 1158
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Miami Valley Hospital - 1115
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Cancer Center - 1107
    • Columbus, Ohio, United States, 43210
      • The Ohio State University James Cancer Center - 1104
    • Massillon, Ohio, United States, 44646
      • Tri County Hematology & Oncology Associates, Inc - 1156
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute - 1154
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oncology Associates of Oregon - 1138
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health Network - 1179
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation - 1135
    • York, Pennsylvania, United States, 17403
      • Cancer Care Associates of York, Inc. - 1113
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center - 1146
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140
    • Denison, Texas, United States, 75020
      • Texas Oncology - Denison - 1139
    • Houston, Texas, United States, 77024
      • Oncology Consultants, P.A. - 1120
    • Laredo, Texas, United States, 78041
      • Oncology and Hematology of South Texas - 1165
    • McAllen, Texas, United States, 78503
      • Texas Oncology - McAllen - 1132
    • San Antonio, Texas, United States, 78240
      • Texas Oncology -San Antonio - 1122
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • NEXT Oncology - Virginia - 1129
    • Henrico, Virginia, United States, 23226
      • Virginia Cancer Institute - 1149
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates - 1136
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia University Cancer Institute - 1172

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria (Major criteria):

1. Adult (≥ 18 years), all genders, capable of signing informed consent.
2. Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs.

3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:

   1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;
   2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.

   Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed.

4. At least one measurable tumor lesion according to RECIST 1.1.
5. ECOG score of 0 or 1.
6. Adequate organ functions. Serum LDH level ≤ 2xULN.
7. Life expectancy ≥ 3 months.

Exclusion Criteria (Major criteria):

1. Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.
2. Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
3. Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
4. Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK;. Exception: KRAS mutations are not excluded.
5. Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
6. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
7. Active interstitial lung disease (ILD) or non-infectious pneumonitis.
8. Active infections with IV antibiotics within 14 days prior to first dose of study treatment.
9. Impaired heart function.

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
Experimental: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W; Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.	Drug: Gotistobart; Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.; Other Names: A humanized anti-CTLA4 IgG1 monoclonal antibody; ONC-392; BNT316
Active Comparator: Arm 2: Docetaxel 75 mg/m2, Q3W; Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.	Drug: Docetaxel; Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.; Other Names: Taxotere; Docefrez

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1	36 months
Objective response rate (ORR)	Objective response rate (ORR) as assessed by the Investigator per RECIST 1.1	36 months
Treatment emergent adverse events, treatment related adverse events and immune related adverse events.	Incidence of TEAEs, TRAEs, irAEs will be calculated. The AEs leading to treatment discontinuation will be recorded.	36 months

Collaborators and Investigators

• Sponsor: OncoC4, Inc.
• Collaborators: BioNTech SE
• Investigators: Principal Investigator: Mark Socinski, MD, Advent Health System; Principal Investigator: Tianhong Li, MD, PhD, University of California, Davis; Principal Investigator: Kai He, MD, PhD, Ohio State University

Publications and helpful links

General Publications

• Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2.
• Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10.
• Cho BC, Balaraman R, Chen HJ, Yu X, Fawole A, Liu ZG, Zhang J, Wu L, Yang B, Leddon JL, Hamm J, Huang Y, Wu L, Pan P, Singh P, Beardsley A, Kayali F, Davarifar A, Lee KH, Park KU, Lee Y, Li L, Wang X, Sun M, Yu Y, Jain V, Shpyro S, Wang Q, Wenger M, Sahin U, Efuni S, Song S, He K, Zheng P, Liu Y, He K, Li T, Socinski MA, Wu YL. Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Nat Med. 2026 Jun;32(6):2245-2253. doi: 10.1038/s41591-026-04323-8. Epub 2026 Mar 27.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: December 31, 2022
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel
• Other Study ID Numbers: PRESERVE-003; 2023-505311-20-01 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No