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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 (PRESERVE-003)
EU CTIS ID: 2023-505311-20-00
What this study is testing
To assess the efficacy of ONC-392 vs. docetaxel as measured by overall survival (OS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult (≥ 18 years), all genders, capable of signing informed consent
- Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs
- Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b: a. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy; b. 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
- At least one measurable tumor lesion according to RECIST 1.1
- ECOG score of 0 or 1
- Adequate organ functions. Serum LDH level ≤ 2xULN
You likely can't join if
- Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy
- Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment
- Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
- Having documented targetable 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
- Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug
- Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease
See the full eligibility criteria
- Adult (≥ 18 years), all genders, capable of signing informed consent
- Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs
- Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b: a. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy; b. 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
- At least one measurable tumor lesion according to RECIST 1.1
- ECOG score of 0 or 1
- Adequate organ functions. Serum LDH level ≤ 2xULN
- Life expectancy ≥ 3 months
- Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy
- Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment
- Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
- Having documented targetable 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
- Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug
- Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease
- Active interstitial lung disease (ILD) or noninfectious pneumonitis
- Uncontrolled fungal or viral infection. Active infections with IV antibiotics within 14 days prior to first dose of study treatment
- Impaired heart function
The study team makes the final eligibility decision.
Where it's taking place
- United States
- China
- Australia
- Turkey
- Korea, Republic of
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; China; Australia; Turkey; Korea, Republic of; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.