ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
Launched by ONCOC4, INC. · Dec 31, 2022
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called gotistobart (ONC-392) for patients with metastatic non-small cell lung cancer (NSCLC) who have not responded to previous treatments using PD-1 or PD-L1 inhibitors. The goal is to see if gotistobart can help patients live longer compared to a standard chemotherapy drug called docetaxel. If you participate, you will be randomly assigned to receive either gotistobart or docetaxel through an intravenous (IV) infusion every three weeks for up to a year.
To be eligible for this trial, you need to be an adult (at least 18 years old) with confirmed metastatic NSCLC that has progressed after specific treatments. You should have at least one measurable tumor and good overall health, with a life expectancy of three months or more. Some patients may not qualify, such as those with certain genetic mutations or active infections. If you join the trial, you’ll help researchers learn more about this new treatment, which could benefit future patients.
Gender
ALL
Eligibility criteria
- 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.
About Oncoc4, Inc.
OncoC4, Inc. is a biopharmaceutical company focused on the development of innovative immunotherapies for the treatment of cancer. Leveraging cutting-edge research and advanced scientific expertise, OncoC4 aims to harness the body’s immune system to combat various malignancies. The company is committed to advancing its proprietary therapeutic candidates through rigorous clinical trials, with the goal of improving patient outcomes and expanding treatment options for those affected by cancer. With a dedicated team of professionals and a robust pipeline, OncoC4 is poised to make significant contributions to the field of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dayton, Ohio, United States
Ocala, Florida, United States
Louisville, Kentucky, United States
Farmington, Connecticut, United States
Milano, , Italy
Immenhausen, , Germany
Elche, , Spain
Goyang Si, , Korea, Republic Of
Lexington, Kentucky, United States
Seoul, , Korea, Republic Of
Bari, , Italy
Orlando, Florida, United States
Messina, , Italy
Esslingen Am Neckar, , Germany
Málaga, , Spain
Columbus, Ohio, United States
Davis, California, United States
York, Pennsylvania, United States
Gettysburg, Pennsylvania, United States
Dothan, Alabama, United States
Cerritos, California, United States
Springfield, Illinois, United States
Cincinnati, Ohio, United States
Sint Niklaas, , Belgium
Bogenhausen, , Germany
Immenstädt, , Germany
Muenchen Gauting, , Germany
Milano, , Italy
Monza, , Italy
Naples, , Italy
Roma, , Italy
Valencia, , Spain
Dothan, Alabama, United States
Russellville, Arkansas, United States
Cerritos, California, United States
Davis, California, United States
Norwalk, Connecticut, United States
Ocala, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
The Villages, Florida, United States
West Palm Beach, Florida, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
East Brunswick, New Jersey, United States
Asheville, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Gettysburg, Pennsylvania, United States
York, Pennsylvania, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Gent, , Belgium
Hasselt, , Belgium
Liège, , Belgium
Sint Niklaas, , Belgium
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Billancourt, , France
Créteil, , France
Bogenhausen, , Germany
Essen, , Germany
Esslingen Am Neckar, , Germany
Immenhausen, , Germany
Immenstädt, , Germany
Muenchen Gauting, , Germany
Ancona, , Italy
Bari, , Italy
Bergamo, , Italy
Messina, , Italy
Milano, , Italy
Milano, , Italy
Monza, , Italy
Naples, , Italy
Palermo, , Italy
Perugia, , Italy
Roma, , Italy
Cheongju Si, , Korea, Republic Of
Daegu, , Korea, Republic Of
Elche, , Spain
Lugo, , Spain
Madrid, , Spain
Málaga, , Spain
Valencia, , Spain
Valencia, , Spain
Orlando, Florida, United States
Newburgh, Indiana, United States
Baton Rouge, Louisiana, United States
Saint Louis Park, Minnesota, United States
Cincinnati, Ohio, United States
Eugene, Oregon, United States
Sayre, Pennsylvania, United States
Denison, Texas, United States
Fort Worth, Texas, United States
Mcallen, Texas, United States
Plano, Texas, United States
Tyler, Texas, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Bankstown, New South Wales, Australia
Newcastle, New South Wales, Australia
Newstead, Queensland, Australia
Adelaide, South Australia, Australia
Fuzhou, Fujian, China
Xiamen, Fujian, China
Dongguan, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Haikou, Hainan, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Suzhou, Jiangsu, China
Xi'an, Shanxi, China
Chongqing, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Tianjin, , China
Essen, , Germany
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Chula Vista, California, United States
Redlands, California, United States
Farmington, Connecticut, United States
Fort Wayne, Indiana, United States
Merriam, Kansas, United States
Jefferson City, Missouri, United States
Knoxville, Tennessee, United States
Henrico, Virginia, United States
Spokane, Washington, United States
Kelowna, British Columbia, Canada
Hefei, Anhui, China
Hefei, Anhui, China
Beijing, Beijing, China
Beijing, Beijing, China
Nanning, Guangxi, China
Zhengzhou, Hebei, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Changsha, Hunan, China
Xuzhou, Jiangsu, China
Nanchang, Jiangxi, China
Jinan, Shandong, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Tianjin, Tianjin, China
Kunming, Yunnan, China
Limoges, , France
Goyang Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Arnhem, , Netherlands
Herzogenbusch, , Netherlands
Adana, , Turkey
Adana, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Antalya, , Turkey
Edirne, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
İzmir, , Turkey
Birmingham, England, United Kingdom
Cambridge, England, United Kingdom
Leicester, England, United Kingdom
London, England, United Kingdom
Manchester, England, United Kingdom
Torquay, England, United Kingdom
Sacramento, California, United States
Walnut Creek, California, United States
Margate, Florida, United States
Topeka, Kansas, United States
Lincoln, Nebraska, United States
Tulsa, Oklahoma, United States
New Lambton Heights, New South Wales, Australia
Québec, , Canada
Beijing, , China
Chengdu, , China
Jiangse, , China
Shandong, , China
Shanghai, , China
Wuhan, , China
Amsterdam, , Netherlands
Tilburg, , Netherlands
Bornova, , Turkey
Fatih, , Turkey
Istanbul, , Turkey
Exeter, England, United Kingdom
Middlesbrough, England, United Kingdom
Massillon, Ohio, United States
Southampton, England, United Kingdom
Edinburgh, Scotland, United Kingdom
Dallas, Texas, United States
London, , United Kingdom
Patients applied
Trial Officials
Mark Socinski, MD
Principal Investigator
Advent Health System
Tianhong Li, MD, PhD
Principal Investigator
University of California, Davis
Kai He, MD, PhD
Principal Investigator
Ohio State University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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