Clinical Trial 23683

• Overview

  Study Title:

  S2414, A 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)

  Summary:

  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. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.

  Objective:

  Primary Objective *To compare disease free survival in stage II-IIIB non-small cell lung cancer participants who achieved a pathologic complete response following standard of care neoadjuvant chemo-immunotherapy and are randomized to adjuvant durvalumab versus surveillance. Secondary Objectives *To compare the overall survival between the arms. *To evaluate the frequency and severity of toxicities of adjuvant durvalumab. *To compare the event free survival between the arms

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  AMP-514 (Durvalumab); Durvalumab (); MEDI4736 (Durvalumab)

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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 had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network [NCCN] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.
  • 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% 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
  • Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy
  • Participants must not have received post-operative radiation therapy (PORT) for NSCLC
  • Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator
  • Participant must be ≥ 18 years old at time of study entry
  • Participants must have body weight > 30 kg
  • Participant must have Zubrod performance status of 0-2
  • Participant must have a complete medical history and physical exam within 28 days prior to randomization
  • Hemoglobin > 9.0 g/dL (within 28 days prior to randomization)
  • Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to randomization)
  • Platelets ≥ 100 x 10^3/uL (within 28 days prior to randomization)
  • Total bilirubin ≤ 1 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)
  • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)
  • Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx
  • Additional criteria may apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Not meeting all of the inclusion criteria.

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