A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

Trial overview


Non-small cell lung cancer

Study details

This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system.

Eligibility criteria

Inclusion Criteria (All Cohorts):

  • Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
  • Prior receipt of at least two prior cycles of platinum-based chemotherapy given concurrently with radiotherapy (cCRT); or at least two prior cycles of platinum-based chemotherapy given prior to radiotherapy (sCRT)
  • The RT component in the cCRT or sCRT must have been at a total dose of radiation of 60 (+/-10%) Gy (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy (preferred) or three dimension (3D)-conforming technique
  • No disease progression during or following platinum-based cCRT or sCRT
  • Documented tumor PD-L1 status (TC score < 1% vs. >/= 1% vs. unknown) as determined: centrally with the SP263 IHC assay on the confirmed available FFPE tumor specimen; locally, with the SP263 (preferred) or 22C3 IHC assays

Inclusion criteria specific to Cohort A1:

  • Centrally confirmed ALK fusion positivity

Inclusion criteria specific to Cohort A2:

  • Centrally confirmed ROS1 fusion positivity

Inclusion criteria specific to Cohort A3:

  • Centrally confirmed RET fusion positivity

Exclusion Criteria (All Cohorts):

  • Any history of previous NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease)
  • Any evidence of Stage IV disease, including, but not limited to, the following: pleural effusion, pericardial effusion, brain metastases, history of intracranial hemorrhage or spinal cord hemorrhage, bone metastases, distant metastases
  • If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (T4 disease): when pleural fluid is visible on both the CT scan and chest X-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; participants with exudative pleural effusions are excluded regardless of cytology; participants with effusions that are minimal (i.e., not visible on chest X-ray) that are too small to safely tap are eligible
  • NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene, as identified by site local testing or Sponsor central testing

Exclusion criteria specific to Cohort A1:

  • Presence of clinically symptomatic interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
  • NSCLC known to have one or more of the following ALK point mutations, as identified by site local testing or Sponsor central testing: I1171X (where X is any other amino acid), V1180L, G1202R
  • Prior treatment with ROS1 inhibitors

Exclusion criteria specific to Cohort A3:

  • Prior treatment with RET inhibitors

Further information

Please click here for more information


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