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Comparing gotistobart to docetaxel for advanced lung cancer after immunotherapy failure

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

Phase 3 Interventional OncoC4, Inc. · NCT05671510

This study is testing if a new treatment called gotistobart can help people with advanced lung cancer live longer after their previous immunotherapy didn't work, compared to the standard chemotherapy drug docetaxel.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment630 (estimated)
Ages18 Years and up
SexAll
SponsorOncoC4, Inc. Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, prednisone
Locations152 sites (Dothan, Alabama and 151 other locations)
Trial IDNCT05671510 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial aims to evaluate the safety and efficacy of gotistobart, a next-generation anti-CTLA-4 antibody, in patients with metastatic non-small cell lung cancer (NSCLC) who have progressed after treatment with PD-1/PD-L1 inhibitors. The study will involve approximately 600 participants who will be randomized to receive either gotistobart or the chemotherapy agent docetaxel, administered via IV infusion every 21 days for up to 17 cycles. The trial consists of two stages: the first stage will confirm the dosing regimen of gotistobart, while the second stage will compare the selected regimen against docetaxel. The goal is to determine if gotistobart can prolong survival compared to standard chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults with metastatic squamous NSCLC who have shown disease progression after prior treatment with PD-1/PD-L1 inhibitors.

Not a fit: Patients who have not received prior PD-1/PD-L1 inhibitor therapy or those with other types of lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option that improves survival for patients with advanced lung cancer who have exhausted other therapies.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Dothan, Alabama and 151 other locations

+102 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.