Phase 3: testing Durvalumab for Lung Non-Small Cell Carcinoma

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Durvalumab. The registry lists allocation as randomized. This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer.

They plan to enroll about 306 people at 284 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)

Interventions: Biospecimen Collection, Computed Tomography, Durvalumab, Patient Observation, Questionnaire Administration

Primary outcome (registry wording): Disease-free survival (DFS)

Who it is for (from inclusion criteria)

• Ages 18 Years to any
• Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)
• Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review
• Participants must have a PD-L1 status result (e.g. \[\< 1% versus \>= 1% or unknown\])
• Participants must not have known EGFR mutations, or ALK gene fusion
• Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines
• Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study
• Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization

Contact

No central phone on the registry card. Use the official listing to reach a site.