Non-Small Cell Lung CancerPhase 1NCT02013219
A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Alectinib, Atezolizumab and Erlotinib in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 17 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Alectinib, Atezolizumab and Erlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 3 Apr 2014to 5 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented, locally advanced or metastatic NSCLC.
- Participants in Stage 1 (Safety Evaluation) receiving erlotinib: No limit to the number of prior therapies (except for EGFR TKIs).
- Participants in Stage 2 (Expansion) receiving erlotinib: i) sensitizing mutation in the EGFR gene and ii) consent to collection of tumor tissue samples before, during, and after treatment for biopsy and PD biomarker analyses.
- Participants receiving alectinib in either Stage 1 or Stage 2: must be ALK positive as assessed by Food and Drug Administration (FDA) approved test and must not have received prior treatment for their advanced NSCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
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- Measurable disease, as defined by RECIST Version 1.1 (v1.1).
- Adequate hematologic and end-organ function.
- Use of highly effective contraception (as defined by protocol) and until 5 months after the last dose of atezolizumab and for 3 months after the last dose of alectinib or for 2 weeks after the last dose of erlotinib, whichever is longer; Males must also refrain from sperm donatation during this same time period. Participants must not be pregnant or breastfeeding.
- Archival tumor tissue specimen meeting protocol specifications or the participant will be offered the option of a pre-treatment biopsy to obtain adequate tissue sample.
Who cannot join
- For participants receiving erlotinib group: prior treatment with any EGFR mutant-targeting TKI
- Any approved anticancer therapy, including chemotherapy, or hormonal therapy (except hormone-replacement therapy or oral contraceptives) within 3 weeks of first dose.
- Treatment with any other test drug or participation in another clinical trial within 28 days of enrollment.
- Known symptomatic central nervous system (CNS) metastases. Participants with a history of treated or untreated asymptomatic CNS metastases may be eligible.
- Leptomeningeal disease.
- Uncontrolled tumor-related pain.
Show all 32Show fewer
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage at least once monthly.
- High levels of calcium requiring bisphosphonate therapy or denosumab.
- Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in-situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ).
- History of severe allergic, anaphylactic, or other reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
- History of autoimmune disease.
- Participants with prior bone marrow or solid organ transplantation.
- History of lung inflammation or disease.
- Serum albumin less than (<) 2.5 grams per deciliter (g/dL).
- Positive for Human Immunodeficiency Virus (HIV).
- Liver disease.
- Current or active tuberculosis, hepatitis B, or hepatitis C.
- Participants with past or resolved hepatitis B virus (HBV) infection are eligible; participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV Riboxy Nucleic Acid (RNA).
- Signs or symptoms of infection within 2 weeks prior to first dosing.
- Received therapeutic oral or IV antibiotics within 2 weeks prior to first dosing.
- Significant cardiovascular disease.
- Major surgical procedure other than for diagnosis within 28 days prior to first dosing or during the course of the study.
- Administration of a live, attenuated vaccine within 4 weeks before first dosing or during the study.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may reasonably prevent the participant from participating.
- Hypersensitivity to erlotinib or alectinib or to any of the excipients.
- Any significant ophthalmologic abnormality. The use of contact lenses is not recommended during the study.
- For participants receiving alectinib: baseline Fridericias corrected QT interval (QTcF) greater than (>) 470 milliseconds (ms) or symptomatic bradycardia.
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies.
- Treatment with systemic immunostimulatory agents within 6 weeks or five half-lives of the drug, whichever is shorter, prior to first dosing.
- Treatment with systemic immunosuppressive medications within 2 weeks prior to first dosing (inhaled corticosteroids and mineralocorticoids are allowed).
- Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication are elgible for study after discussion and approval by the Medical Monitor.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
United States10 sites
Massachusetts General Hospital;Hematology/ Oncology
Boston, Massachusetts, 02114
Beth Israel Deaconess Med Ctr; Neurology/MS Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Case Western Reserve University; Medicine-Hematology and Oncology
Cleveland, Ohio, 44106
Karmanos Cancer Center; Department of Oncology
Detroit, Michigan, 48201
Yale University School Of Medicine
New Haven, Connecticut, 06510
Memorial Sloan Kettering - Basking Ridge
New York, New York, 10065
UC Irvine Medical Center
Orange, California, 92868
Florida Hospital Cancer Inst
Orlando, Florida, 32804
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Spain2 sites
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050
Hospital Clinico Universitario de Valencia
Valencia, 46010
About this study
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.
Read more
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Alectinib, Atezolizumab, Erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
Also called Alecensa
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.
AtezolizumabDrug
Also called TECENTRIQ, MPDL3280A
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.
ErlotinibDrug
Also called Tarceva
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Alectinib and Atezolizumab | Experimental | 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. Receives: Drug: Alectinib; Drug: Atezolizumab |
| Stage 1: Erlotinib and Atezolizumab | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Erlotinib |
| Stage 2: Alectinib and Atezolizumab | Experimental | 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. Receives: Drug: Alectinib; Drug: Atezolizumab |
| Stage 2: Erlotinib and Atezolizumab | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Measured: 28 days
Recommended Phase II Dose (RP2D) of Atezolizumab and Erlotinib
Measured: 28 days
Recommended RP2D of Atezolizumab and Alectinib
Measured: 28 days
Secondary outcomes (13)
Minimum Plasma Concentration (Cmin) of Alectinib and Major Metabolites, as Appropriate
Measured: 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)
Measured: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
Overall Survival
Measured: 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
Measured: Baseline up to disease progression or death from any cause (up to approximately 6 years)
Percentage of Participants with Adverse Events
Measured: Baseline up to approximately 6 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) Against Atezolizumab
Measured: Baseline up to approximately 6 years
Maximum Serum Concentration (Cmax) of Atezolizumab
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline up to disease progression or death from any cause (up to approximately 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study start3 Apr 2014
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013219
- Sponsor's protocol ID
- WP29158
- Other IDs
- 2013-004382-13
- Status last verified
- Apr 2020
- First submitted
- 11 Dec 2013
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02013219
- Acronym / sponsor ID
- WP29158
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2014 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Alectinib and Atezolizumab | Experimental | Drug: Alectinib, Drug: AtezolizumabIn 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. |
| Stage 1: Erlotinib and Atezolizumab | Experimental | Drug: Atezolizumab, Drug: ErlotinibIn 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. |
| Stage 2: Alectinib and Atezolizumab | Experimental | Drug: Alectinib, Drug: AtezolizumabIn 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. |
| Stage 2: Erlotinib and Atezolizumab | Experimental | Drug: Atezolizumab, Drug: ErlotinibIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically documented, locally advanced or metastatic NSCLC.
- Participants in Stage 1 (Safety Evaluation) receiving erlotinib: No limit to the number of prior therapies (except for EGFR TKIs).
- Participants in Stage 2 (Expansion) receiving erlotinib: i) sensitizing mutation in the EGFR gene and ii) consent to collection of tumor tissue samples before, during, and after treatment for biopsy and PD biomarker analyses.
- Participants receiving alectinib in either Stage 1 or Stage 2: must be ALK positive as assessed by Food and Drug Administration (FDA) approved test and must not have received prior treatment for their advanced NSCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (32 listed)
- For participants receiving erlotinib group: prior treatment with any EGFR mutant-targeting TKI
- Any approved anticancer therapy, including chemotherapy, or hormonal therapy (except hormone-replacement therapy or oral contraceptives) within 3 weeks of first dose.
- Treatment with any other test drug or participation in another clinical trial within 28 days of enrollment.
- Known symptomatic central nervous system (CNS) metastases. Participants with a history of treated or untreated asymptomatic CNS metastases may be eligible.
- Leptomeningeal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlectinibAlso: AlecensaParticipants 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. | Drug | Stage 1: Alectinib and Atezolizumab, Stage 2: Alectinib and Atezolizumab |
| AtezolizumabAlso: TECENTRIQ, MPDL3280AParticipants 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. | Drug | Stage 1: Alectinib and Atezolizumab, Stage 1: Erlotinib and Atezolizumab, Stage 2: Alectinib and Atezolizumab, Stage 2: Erlotinib and Atezolizumab |
| ErlotinibAlso: TarcevaParticipants 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. | Drug | Stage 1: Erlotinib and Atezolizumab, Stage 2: Erlotinib and Atezolizumab |
Primary outcome
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
13 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alectinib, Atezolizumab and Erlotinib in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, South Korea, Spain, France, Hong Kong and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Dose-Limiting Toxicities (DLTs) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.