Active — Not RecruitingPhase 3

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

United States730 participantsStarted 2018-09-27

Plain-language summary

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
✓. Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
✓. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.

Exclusion criteria

✕. Extensive-stage SCLC
✕. Active or prior documented autoimmune or inflammatory disorders
✕. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
✕. Active infection including tuberculosis, HIV, hepatitis B and C
✕. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)

What they're measuring

Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1

Timeframe: Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)

Durvalumab Versus Placebo: Overall Survival (OS)

Timeframe: From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)

Trial details

NCT IDNCT03703297

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-15

Results submitted2025-05-23

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