Ignite Creation Date:
2024-05-06 @ 2:20 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02013219
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2013-12-11
Brief Title:
A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer NSCLC
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-004382-13 | EUDRACT_NUMBER | None | None |