Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1b Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered With Erlotinib or Alectinib in Patients With Advanced Non-Small Cell Lung Cancer
This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics
of intravenous (IV) dosing of atezolizumab in combination with oral erlotinib or alectinib in
participants with NSCLC.
This study has two stages. In the erlotinib group, the combination treatment will be given to
participants with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor
(TKI)-treatment-naive, advanced (nonresectable) NSCLC in a safety-evaluation stage and to
participants with previously untreated EGFR mutation-positive, advanced NSCLC in an expansion
stage (Stage 2). In the alectinib group, for both the safety-evaluation and expansion stages
(Stages 1 and 2), the combination will be given to participants who are treatment-naive with
anaplastic lymphoma kinase (ALK)-positive advanced NSCLC.
In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) by mouth (PO)
once daily (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28
consecutive days during Cycle 1 and on Days 1 through 21 of each cycle thereafter. The
starting dose of atezolizumab will be 1200 mg, administered every 3 weeks (q3W) starting on
Day 8 of Cycle 1. If the starting regimen for a combination treatment is not tolerated,
alternative doses and/or schedules of erlotinib and atezolizumab or alectinib and
atezolizumab may be tested to determine potential recommended Phase 2 dose (RP2D) for that
combination treatment. In Stage 2, a potential RP2D and schedule for each combination
treatment will be investigated in an expansion cohort.
For both stages, continuation of treatment beyond Cycle 1 will be at the discretion of the
treating investigator. Study treatment will be discontinued in participants who experience
disease progression or unacceptable toxicity, are not compliant with the study protocol, or,
in their opinion or in the opinion of the investigator, are not benefiting from study
treatment. However, in the absence of unacceptable toxicity, participants with second-line or
greater NSCLC who are still receiving atezolizumab at the time of radiographic disease
progression may be permitted to continue study treatment.
n/a
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