Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA
Dates
study started
estimated completion

Description

Summary

This trial will evaluate the efficacy and safety of targeted therapies in participants with resectable Stage IA2, IB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors with selected molecular alterations.

Official Title

Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Alectinib, Entrectinib, or Vemurafenib Plus Cobimetinib in Patients With Stages I-III Non-Small Cell Lung Cancer With ALK, ROS1, NTRK, or BRAF v600E Molecular Alterations

Keywords

Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Vemurafenib Entrectinib Alectinib Cobimetinib Resection Radiotherapy Chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

Neoadjuvant Therapy:

  • Pathologically documented NSCLC
  • Molecular testing results from Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories and showing at least one of the following abnormalities: ALK gene rearrangement; ROS1 gene rearrangement; NTRK1/2/3 gene rearrangement; BRAF V600 mutation
  • Molecular testing results used for patient eligibility should be obtained from the most recent tumor biopsy. Alternatively, and for patients with ALK, ROS1, and NTRK1/2/3 molecular alterations, molecular testing results used to determine patient eligibility could have been obtained from a recent blood sample (up to 2 months prior to enrollment) described in the study design
  • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • NSCLC must have a solid or subsolid appearance on computed tomography (CT) scan and cannot have a purely ground glass opacity appearance. For sub-solid lesions, the tumor size (i.e., clinical T stage) should be measured based on the solid component only, exclusive of the ground glass opacity component
  • Evaluated by the attending surgeon prior to study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and verify that the patient is medically operable
  • Adequate pulmonary function to be eligible for surgical resection with curative intent
  • Adequate cardiac function to be eligible for surgical resection with curative intent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate hematologic and end-organ function
  • Male patients must be willing to use acceptable methods of contraception. Treatment-specific contraceptive requirements will be in the specific protocol appendix for each study drug
  • Female patients of childbearing potential must agree to use acceptable methods of contraception. For treatment-specific contraceptive requirements, please see the specific appendix for each study drug

Adjuvant Therapy:

  • Patients whose tumors have pathologic response or lack of radiographic progression
  • ECOG Performance Status of 0 or 1
  • Adequate hematologic and end-organ function

You CAN'T join if...

  • NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease
  • Any prior therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 2 years
  • Patients with prior lung cancer that have been in remission for < 2 years with the exception of minimally invasive adenocarcinoma or incidental typical carcinoid tumors
  • Major surgical procedure within 28 days prior to Cycle 1, Day 1
  • Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of patients with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, non-muscle invasive bladder cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per SOC management (e.g., Rai Stage 0 chronic lymphocytic leukemia, prostate cancer with Gleason score </= 6, and prostate-specific antigen (</= 10 ng/mL, etc.)
  • Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1 (or within 5 half-lives of the investigational product, whichever is longer)
  • Known HIV positivity or AIDS-related illness
  • Pregnant or lactating, or intending to become pregnant during the study

Locations

  • UCLA Jonssen Comprehensive Cancer Center not yet accepting patients
    Los Angeles California 90095-1781 United States
  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Cedars-Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange not yet accepting patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT04302025
Phase
Phase 2
Study Type
Interventional
Last Updated