A Phase 1 interventional study of Alectinib and Atezolizumab in Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 17 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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.
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Exclusion Criteria:
In Stage 1, starting dose of atezolizumab will be 1200 mg IV q3w administered on Day 8 of Cycle 1 and on Day 1 (21-day cycle) of each cycle thereafter along with alectinib at a starting dose of 600 mg PO BID for 28 consecutive days during Cycle 1 and on Days 1-21 of each cycle thereafter; unless maximum tolerable dose (MTD) is exceeded. The combination will be given to treatment-naive participants with ALK-positive, locally advanced or metastatic NSCLC.
Drug: Alectinib · Drug: Atezolizumab
In Stage 1, starting dose of atezolizumab will be 1200 mg IV q3w administered on Day 8 of Cycle 1 and on Day 1 (21-day cycles) of each cycle thereafter along with erlotinib at a starting dose of 150 mg PO QD, for 28 consecutive days during Cycle 1 and on Days 1-21 of each cycle thereafter; unless MTD is exceeded. The combination will be given to participants with EGFR TKI treatment-naive, locally advanced or metastatic NSCLC.
Drug: Atezolizumab · Drug: Erlotinib
In Stage 2, participants received the RP2D on the basis of the MTD or maximum allowed dose (MAD) of the combination treatment established in Stage 1. Treatment-naive participants with ALK-positive, locally advanced or metastatic NSCLC will be included.
Drug: Alectinib · Drug: Atezolizumab
In Stage 2, participants received the RP2D on the basis of the MTD or MAD of the combination treatment established in Stage 1. Previously untreated (or with one prior treatment that was not an EGFR TKI), EGFR mutation positive, locally advanced or metastatic NSCLC participants will be included.
Drug: Atezolizumab · Drug: Erlotinib
Participants will receive 600 mg PO alectinib BID for 28 consecutive days during Cycle 1 and on Days 1-21 of each cycle thereafter (21-day cycles from Cycle 2 onwards) in Stage 1 and RP2D PO BID in Stage 2.
Also known as: Alecensa
Participants will receive 1200 mg atezolizumab IV infusion q3w on Day 8 of Cycle 1 and on Day 1 of each cycle thereafter in Stage 1 and in Stage 2.
Also known as: TECENTRIQ, MPDL3280A
Participants will receive 150 mg erlotinib PO QD for 28 consecutive days during Cycle 1 and on Days 1-21 of each cycle thereafter in Stage 1 (21-day cycles from Cycle 2 onwards) and RP2D PO QD in Stage 2.
Also known as: Tarceva
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: 28 days
Recommended Phase II Dose (RP2D) of Atezolizumab and Erlotinib
Time frame: 28 days
Recommended RP2D of Atezolizumab and Alectinib
Time frame: 28 days
Minimum Plasma Concentration (Cmin) of Alectinib and Major Metabolites, as Appropriate
Time frame: Pre-dose (0 hour) on Day 1 of Cycles 1-4, Day 8 of Cycle 1 (Cycle 1 =28 days; Cycle 2 onwards=21 days)
Progression-Free Survival (PFS) as Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
Overall Survival
Time frame: First dose of study treatment up to death from any cause during the study (up to approximately 6 years)
Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Using RECIST
Time frame: Baseline up to disease progression or death from any cause (up to approximately 6 years)
Percentage of Participants with Adverse Events
Time frame: Baseline up to approximately 6 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) Against Atezolizumab
Time frame: Baseline up to approximately 6 years
Maximum Serum Concentration (Cmax) of Atezolizumab
Time frame: Day 1 of Cycles 1-4, Day 8 of Cycle 1 (Cycle 1 =21 days; Cycle 2 onwards=28 days)
Minimum Serum Concentration (Cmin) of Atezolizumab
Time frame: Pre-dose (0 hour) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 and at study termination (up to approximately 5 years; Cycle 1=21 days; Cycle 2 onwards=28 days)
Maximum Plasma Concentration (Cmax) of Erlotinib
Time frame: Day 1 of Cycles 1-4, Day 8 of Cycle 1 (Cycle 1 =21 days; Cycle 2 onwards=28 days)
Minimum Plasma Concentration (Cmin) of Erlotinib
Time frame: Pre-dose (0 hour) on Day 1 of Cycles 1-4, Day 8 of Cycle 1 (Cycle 1 =21 days; Cycle 2 onwards=28 days)
Maximum Plasma Concentration (Cmax) of Alectinib and Major Metabolites, as Appropriate
Time frame: Day 1 of Cycles 1-4, Day 8 of Cycle 1 (Cycle 1 =21 days; Cycle 2 onwards=28 days)
Duration of Objective Response as Assessed Using RECIST
Time frame: First occurrence of a documented objective response up to disease progression or death from any cause (up to approximately 6 years)
Percentage of Participants with Best Overall Response
Time frame: Baseline up to disease progression or death from any cause (up to approximately 6 years)
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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