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Efficacy of Immune Checkpoint Inhibitor Combination Chemotherapy in Patients with Recurrent NSCLC After Durvalumab Consolidation Following Chemoradiotherapy: A Multicenter Retrospective Study

Efficacy of Immune Checkpoint Inhibitor Combination Chemotherapy in Patients with Recurrent NSCLC After Durvalumab Consolidation Following Chemoradiotherapy: A Multicenter Retrospective Study - NEJ066 study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000058332
Enrollment
250
Registered
2025-07-03
Start date
2024-10-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

None listed

Sponsors

Specified Nonprofit Corporation North East Japan Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with non-small cell lung cancer based on histological or cytological examination. 2. Among patients who received durvalumab as consolidation therapy following chemoradiotherapy, those who either: completed 1 year of durvalumab treatment,or discontinued consolidation therapy for reasons other than disease progression. 3. Patients who, between August 1, 2018 and March 31, 2023, received a platinum-doublet regimen as first-line therapy after recurrence at participating research institutions. The use of immune checkpoint inhibitors [PD-1 inhibitors / PD-L1 inhibitors with or without CTLA-4 inhibitors], anti-VEGF agents, or anti-EGFR monoclonal antibodies in combination is permitted.Patients who underwent prior local treatment for metastatic lesions [e.g., brain or bone metastases] before first-line therapy after recurrence may also be included.

Exclusion criteria

Exclusion criteria: 1. Patients positive for EGFR, ALK, ROS1, or RET gene mutations. 2. Patients who showed disease progression on the first systemic evaluation performed after completion or discontinuation of durvalumab consolidation therapy. 3. Patients who have expressed a refusal to participate in this study. 4. Patients deemed unsuitable for participation in this study by the principal investigator or sub-investigators.

Design outcomes

Primary

MeasureTime frame
Progression free survival

Secondary

MeasureTime frame
Overall survival, Objective response rate, Adverse events

Countries

Japan

Contacts

Public ContactHirokazu Iso

The Cancer Institute Hospital of JFCR Department of Thoracic Medical Oncology

hirokazu.iso@jfcr.or.jp0335200111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026