Study Comparing IBI363 and Docetaxel for Advanced Squamous Lung Cancer After Standard Treatments Have Failed
Sponsor: Fortvita Biologics (USA)Inc.
ClinicalTrials ID:NCT07217301
This clinical trial is testing two treatments, IBI363 and Docetaxel, to see which is more effective for patients with advanced squamous lung cancer that has not responded to standard treatments. The study involves about 600 participants and is conducted across multiple regions.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the effectiveness of a new drug, IBI363, with the standard chemotherapy drug, Docetaxel, in treating advanced squamous non-small cell lung cancer (NSCLC) that has not responded to previous treatments. Participants will be randomly assigned to receive either IBI363 or Docetaxel, and the study will evaluate which treatment works better in controlling the cancer.
Eligibility Criteria
Inclusion Criteria
- Must be willing to sign a consent form and follow the study schedule and procedures.
- Must be 18 years or older.
- Have advanced or metastatic squamous non-small cell lung cancer that cannot be removed by surgery.
- Cancer must have resisted or returned after standard treatments, including platinum-based chemotherapy and PD-1/PD-L1 immunotherapy.
- Must show cancer progression on scans during or within 6 months after stopping PD-1/PD-L1 treatment.
- Agree to provide a tumor sample for testing.
- Have at least one measurable tumor on a scan.
- Be in good general health with an ECOG performance status of 0 or 1.
- Expected to live at least 3 more months.
- Women of childbearing potential and men with partners of childbearing potential must use effective birth control during and for 6 months after treatment.
- Women must not breastfeed during and for 6 months after treatment.
Exclusion Criteria
- Women who are pregnant or breastfeeding, or planning to become pregnant during or within 6 months after treatment.
- Have certain genetic mutations that have approved targeted treatments.
- Have active or untreated brain metastases, unless stable for at least 4 weeks after treatment.
- Have certain blood or liver test abnormalities.
- Have a history of serious blood clots or bleeding issues.
- Have significant heart or lung diseases.
- Have uncontrolled infections or other serious medical conditions.
- Have a history of severe allergic reactions to study drugs.
- Have not recovered from previous cancer treatments or surgeries.
- Have other active cancers, except for certain skin or prostate cancers.
- Have received certain medications or treatments that are not allowed in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fortvita Biologics | 94043 | Mountain View | California |
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