STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1
Sponsor: M.D. Anderson Cancer Center
No open prediction endpoints
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Primary Endpoints (CT.gov)
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year
Eligibility Criteria
Eligibility Criteria 1. Voluntarily sign a written informed consent form 2. Age ≥ 18 years old at the time of enrollment 3. Ability of comply with the study protocol, in the investigator's judgement 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 5. Expected life expectancy ≥ 3 months 6. Metastatic (Stage IV) NSCLC, according to American Joint Committee on Cancer (AJCC) 8th edition 7. Histologically or cytologically confirmed lung squamous cell carcinoma (LSCC). Participants with mixed histology (eg, adenosquamous) are allowed if there is squamous component. 8. Disease progression during or following treatment with platinum doublets and anti-PD(L)1 containing therapy for metastatic LSCC. 9. At least one measurable noncerebral lesion according to RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions since radiotherapy. Sites of biopsy cannot be included as target le…
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