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Last Updated: November 27, 2022

CLINICAL TRIALS PROFILE FOR ALECENSA


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All Clinical Trials for Alecensa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02013219 ↗ A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC) Completed Hoffmann-La Roche Phase 1 2014-04-03 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.
NCT02091141 ↗ My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Active, not recruiting Genentech, Inc. Phase 2 2014-04-14 This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.
NCT02314481 ↗ Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity Recruiting Hoffmann-La Roche Phase 2 2017-05-12 DARWIN II is a multi-arm non-randomised phase II trial, Eligible patient will be those who relapse with NSCLC (clinical trials.gov ref. NCT02183883). Patients must have at least two tissue/DNA samples of their disease available for sequencing. The trial will investigate assess if intra-tumour heterogeneity (clonal vs subclonal actionable mutation) is associated with PFS. Patients without an actionable mutation will receive MPDL3280A (atezolizumab), a monoclonal antibody targeting anti-PDL1, as monotherapy or in combination with chemotherapy, The options for combination therapy will vary depending on the histology of the NSCLC (i.e. non-squamous or squamous). Patients with BRAFV600 mutations, HER2 Amplification, ALK/RET gene rearrangements will be enrolled into arms treating with vemurafenib, trastuzumab emtansine and alectinib respectively. DARWIN II will include extensive exploratory biomarker analysis to investigate a number of genomic and immune markers that may predict response to MPDL3280A (atezolizumab) and help guide future clinical trial design.
NCT02314481 ↗ Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity Recruiting University College, London Phase 2 2017-05-12 DARWIN II is a multi-arm non-randomised phase II trial, Eligible patient will be those who relapse with NSCLC (clinical trials.gov ref. NCT02183883). Patients must have at least two tissue/DNA samples of their disease available for sequencing. The trial will investigate assess if intra-tumour heterogeneity (clonal vs subclonal actionable mutation) is associated with PFS. Patients without an actionable mutation will receive MPDL3280A (atezolizumab), a monoclonal antibody targeting anti-PDL1, as monotherapy or in combination with chemotherapy, The options for combination therapy will vary depending on the histology of the NSCLC (i.e. non-squamous or squamous). Patients with BRAFV600 mutations, HER2 Amplification, ALK/RET gene rearrangements will be enrolled into arms treating with vemurafenib, trastuzumab emtansine and alectinib respectively. DARWIN II will include extensive exploratory biomarker analysis to investigate a number of genomic and immune markers that may predict response to MPDL3280A (atezolizumab) and help guide future clinical trial design.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Alecensa

Condition Name

Condition Name for Alecensa
Intervention Trials
Non-small Cell Lung Cancer 6
Neoplasms 3
Solid Tumors 3
Respiratory Tract Diseases 1
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Condition MeSH

Condition MeSH for Alecensa
Intervention Trials
Lung Neoplasms 10
Carcinoma, Non-Small-Cell Lung 10
Neoplasms 4
Ovarian Neoplasms 2
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Clinical Trial Locations for Alecensa

Trials by Country

Trials by Country for Alecensa
Location Trials
United States 134
France 9
China 9
Spain 8
Italy 8
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Trials by US State

Trials by US State for Alecensa
Location Trials
California 8
New York 7
Massachusetts 6
Texas 6
Illinois 5
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Clinical Trial Progress for Alecensa

Clinical Trial Phase

Clinical Trial Phase for Alecensa
Clinical Trial Phase Trials
Phase 3 1
Phase 2 13
Phase 1/Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Alecensa
Clinical Trial Phase Trials
Recruiting 11
Active, not recruiting 3
Terminated 2
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Clinical Trial Sponsors for Alecensa

Sponsor Name

Sponsor Name for Alecensa
Sponsor Trials
Hoffmann-La Roche 5
Genentech, Inc. 5
Takeda 2
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Sponsor Type

Sponsor Type for Alecensa
Sponsor Trials
Other 24
Industry 21
NIH 1
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