Active — Not RecruitingPhase 2

Phase II Clinical Study of Adebrelimab Combined with Apatinib in the Treatment of Locally Advanced Non-small Cell Lung Cancer Patients with Radiation Pneumonitis

China32 participantsStarted 2024-08-13

Plain-language summary

A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years old, male or female;
✓. ECOG PS score 0-1;
✓. The expected survival time is not less than 12 weeks;
✓. Histologically or cytologically confirmed non-small cell lung cancer patients with unresectable locally advanced (stage III) (AJCC TNM staging, 8th edition);
✓. Patients who are not candidates for EGFR, ALK, or ROS1 targeted therapy, as confirmed by histologic or cytologic specimens (with documented evidence of no EGFR sensitizing mutation, ALK gene rearrangement, or ROS1 gene fusion);
✓. Patients with grade 2 or below radiation pneumonitis without disease progression after receiving platinum-based concurrent/sequential chemoradiotherapy;
✓. First dose was administered on days 1-42 (up to 42 days) after completion of concurrent/sequential platinum-based chemoradiotherapy for grade ≤1 RP; Patients with grade 2 RP who were downgraded to less than grade 1 RP within 56 days (including 56 days) after concurrent/sequential chemoradiotherapy received the first medication, and consolidation chemotherapy after radiotherapy was not allowed during the period.

Exclusion criteria

✕. Histological types of mixed small cell lung cancer and non-small cell lung cancer;
✕. Disease progression after chemoradiotherapy; Had undergone major surgery within 28 days before the first dose of a study drug or was planned to undergo major surgery during the study (at the investigator's discretion); 3.

What they're measuring

Progression free survival (PFS)

Timeframe: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months

Trial details

NCT IDNCT06700421

SponsorWei Zhou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Unresectable Locally Advanced Non-small Cell Lung Cancer trials