NCT05568212

Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab

Phase II, Two-cohorts, Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab (MEDI4736)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Fondazione Ricerca Traslazionale · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, non-comparative, phase II study investigating whether: 1) the addition of durvalumab to investigator's choice second line chemotherapy prolongs survival versus investigator's choice second line chemotherapy in NSCLC patients with locally advanced disease progressing on durvalumab given after concomitant chemoradiotherapy; 2) whether the addition of olaparib to durvalumab improves survival over durvalumab alone after induction chemoimmunotherapy in patients relapsing after completing durvalumab maintenance therapy for stage III disease. After evaluation of inclusion and exclusion criteria and after consent form signature, all eligible patients progressing during durvalumab therapy will be in the Part A of the trial randomized to in a 1:1 ratio to investigator's choice single-agent chemotherapy plus durvalumab (Arm A: experimental arm) or to investigator's choice single-agent chemotherapy (Arm B: standard arm). In the clinical trial's Part B, patients progressing after completion of durvalumab therapy will be further randomized in a 1:1.7 ratio to investigator's choice platinum doublet chemotherapy plus durvalumab for 4 cycles followed by maintenance durvalumab plus olaparib (Arm C: experimental arm) or to investigator's choice platinum doublet chemotherapy plus durvalumab for 4 cycles followed by durvalumab (Arm D: experimental arm). Therapy will be continued up to disease progression, toxicity or patient refusal.

Conditions

• Non-small-cell Lung Cancer Patients

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab concentrate for solution for infusion will be supplied in glass vials containing 500 mg durvalumab at a concentration of 50 mg/mL
DRUG	Olaparib tablet	Olaparib tablets (100 mg and 150 mg strengths) supplied in high-density polyethylene (HDPE) bottles.
DRUG	Single-agent chemotherapy	Investigator's choice single-agent chemotherapy regimen
DRUG	Platinum doublet chemotherapy	Investigator's choice platinum doublet chemotherapy

Timeline

• Start date: 2022-05-02
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2022-10-05
• Last updated: 2025-12-01

Locations

1 site across 1 country: Italy