A Study of Amivantamab and Lazertinib in Combination with Chemotherapy Compared with Chemotherapy in Patientswith Locally Advanced or Metastatic Non Small Cell Lung Cancer After Osimertinib Failure
- Conditions
- Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
- Registration Number
- CTRI/2022/01/039158
- Lead Sponsor
- Johnson and Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Participant must have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors RECIST version 1 point 1 that has not been previously irradiated Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer NSCLC, characterized at or after the tine of locally advanced metastatic disease diagnosis by either epidermal growth factor receptor EGFR Exon 19del or Exon 21 L858R mutation A participant with definitively locally treated brain metastases must be clinically stable and asymptomatic, with or without low-dose corticosteroid treatment less than or equal to 10 milligrams mg prednisone or equivalent, for at least 14 days prior to randomization Participant must have Eastern Cooperative Oncology Group ECOG status of 0 or 1 Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE Version 5 point 0 Grade 1 or baseline level except for alopecia any grade, Grade less than or equal to 2 peripheral neuropathy, or Grade less than or equal to two hypothyroidism stable on hormone replacement A woman of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second line setting after prior treatment with first or second generation EGFR tyrosine kinase inhibitor TKI. Participants who received either neoadjuvant and/or adjuvant treatment are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days 4 half lives prior to randomization that is last dose no later than Day 8
Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
Participant has active brain metastases not definitively treated with local therapy
Participant has leptomeningeal disease or participant has spinal cord compression not definitively treated with surgery or radiation
Participant has known small cell transformation
Participant has a medical history of interstitial lung disease ILD including drug induced ILD or radiation pneumonitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) <br/ ><br>According to RECIST v1.1 Guidelines as Assessed by Blinded Independent Central <br/ ><br>Review (BICR)Timepoint: Upto 17 months
- Secondary Outcome Measures
Name Time Method