SWOG clinical trial number
S2414
INcorporating pathologic reSponse in patIents with early staGe lung cancer to optimize immunotHerapy in the adjuvanT setting (INSIGHT)
Open
Phase
Abbreviated Title
Immunotherapy after Surgery for People Who Have No Remaining Cancer Cells in Resected Tissues After Chemo-immunotherapy and Surgery as Treatment for Early-Stage Non-Small Cell Lung Cancer
Status Notes
Initial Activation-Effective March 14, 2025, at 12:00 p.m. Pacific Time
Activated
03/14/2025
Research committees
Lung Cancer
Symptom Control and Quality of Life
Treatment
durvalumab
Eligibility Criteria Expand/Collapse
Stage II-IIIB NSCLC (excluding clinical N3 disease).
Complete (R0) resection within 84 days prior to randomization, with appropriate lymph node sampling per NCCN Guidelines.
Acceptable surgical resections: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy (wedge resection not allowed).
NCCN Guidelines: Minimum of one N1 and three N2 stations sampled or complete lymph node dissection required. Formal ipsilateral mediastinal lymph node dissection required for N2 disease.
Pathologic complete response (pCR) required (no viable tumor in resected specimen or lymph nodes, per local pathology review).
PD-L1 status must be determined (<1%, >=1%, or unknown).
Exclusion criteria: Known EGFR mutations or ALK gene fusion.
Neoadjuvant therapy: Minimum of two cycles of FDA-approved, standard-of-care platinum-based chemotherapy + anti-PD-1/PD-L1 therapy per NCCN guidelines.
No concurrent treatment: No non-protocol chemotherapy, immunotherapy, biologic, or hormonal therapy for NSCLC.
No recent systemic therapy: No chemotherapy, immunotherapy, or investigational drugs within 28 days prior to randomization.
No contraindications: Must not have medical contraindications or severe AEs to anti-PD-1/PD-L1 therapy.
No prior PORT: Participants must not have received post-operative radiation therapy.
No unresolved Grade >= 2 toxicity (except alopecia, vitiligo); Grade >= 2 neuropathy and irreversible toxicity may be allowed at investigator discretion.
Please see Protocol Section 5 for full details
Complete (R0) resection within 84 days prior to randomization, with appropriate lymph node sampling per NCCN Guidelines.
Acceptable surgical resections: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy (wedge resection not allowed).
NCCN Guidelines: Minimum of one N1 and three N2 stations sampled or complete lymph node dissection required. Formal ipsilateral mediastinal lymph node dissection required for N2 disease.
Pathologic complete response (pCR) required (no viable tumor in resected specimen or lymph nodes, per local pathology review).
PD-L1 status must be determined (<1%, >=1%, or unknown).
Exclusion criteria: Known EGFR mutations or ALK gene fusion.
Neoadjuvant therapy: Minimum of two cycles of FDA-approved, standard-of-care platinum-based chemotherapy + anti-PD-1/PD-L1 therapy per NCCN guidelines.
No concurrent treatment: No non-protocol chemotherapy, immunotherapy, biologic, or hormonal therapy for NSCLC.
No recent systemic therapy: No chemotherapy, immunotherapy, or investigational drugs within 28 days prior to randomization.
No contraindications: Must not have medical contraindications or severe AEs to anti-PD-1/PD-L1 therapy.
No prior PORT: Participants must not have received post-operative radiation therapy.
No unresolved Grade >= 2 toxicity (except alopecia, vitiligo); Grade >= 2 neuropathy and irreversible toxicity may be allowed at investigator discretion.
Please see Protocol Section 5 for full details
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