Back to resultsA Study Evaluating the Safety, Activity, and Pharmacokinetics of GDC-6036 in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Primary Purpose
Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GDC-6036
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Confirmation of Biomarker eligibility Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy No prior systemic treatment for advanced unresectable or metastatic NSCLC Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Exclusion Criteria: Known concomitant second oncogenic driver with available targeted treatment Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Prior treatment with a KRAS G12C inhibitor Known hypersensitivity to any of the components of GDC-6036 or pembrolizumab History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
Sites / Locations
- Hospital Britanico; OncologiaRecruiting
- Clinica Adventista Belgrano; OncologyRecruiting
- Centro Oncologico Riojano Integral (CORI)Recruiting
- Concord Repatriation General Hospital; Concord Cancer CentreRecruiting
- Alfred HealthRecruiting
- Jessa Zkh (Campus Virga Jesse)Recruiting
- Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
- Pusan National University HospitalRecruiting
- Asan Medical CenterRecruiting
- Korea University Guro HospitalRecruiting
- NKI The Netherlands Cancer InstituteRecruiting
- Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych FazRecruiting
- Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? OnkologicznyRecruiting
- Vall d?Hebron Institute of Oncology (VHIO), BarcelonaRecruiting
- Hospital General Universitario Gregorio Marañon; Servicio de OncologiaRecruiting
- Hospital Universitario Virgen del Rocio; Servicio de OncologiaRecruiting
- Sahlgrenska University Hospital; Sahlgrenska Clinical Trial unit / Department of OncologyRecruiting
- National Cheng Kung University Hospital; Internal MedicineRecruiting
- National Taiwan Uni Hospital; Internal MedicineRecruiting
- Chang Gung Medical Foundation - Linkou; Chest DeptRecruiting
- Adana City Hospital, Medical Oncology
- Ankara Bilkent City Hospital
- Koc University Hospital; Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Expansion
Combination Dose Finding + Expansion
Arm Description
Participants enrolled in this cohort will receive GDC-6036 once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).
During the expansion stage, some participants are planned to be randomized to one GDC-6036 combination dose level; other participants are planned to be randomized to another GDC-6036 combination dose level. GDC-6036 will be given in combination with pembrolizumab.
Outcomes
Primary Outcome Measures
Percentage of Participants with Adverse Events (AEs)
Secondary Outcome Measures
Objective Response Rate (ORR)
The percentage of participants who experience a complete response or partial response, as determined by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Duration of Response (DOR)
The time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Progression Free Survival (PFS)
The time from randomization, or date of first treatment for participants enrolled prior to the expansion stage, to the first occurrence of disease progression or death from any cause during the study (whichever occurs first), as determined by the investigator according to RECIST v1.1
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Side Effects as Assessed Through the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Change from Baseline in Symptomatic Side Effects, as Assessed Through use of the PRO-CTCAE
Percentage of Participants Reporting "Frequent" or "Almost Constant" Diarrhea During the First Three Cycles of Treatment According to the PRO-CTCAE Criteria
Percentage of Participants Reporting "Severe" or "Very Severe" Nausea or Vomiting During the First Three Cycles of Treatment According to the PRO-CTCAE
Frequency of Participant's Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the Single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46)
Plasma concentration of GDC-6036 at Specified Timepoints
Identification of GDC-6036 Recommended Dose
The recommended dose will be based upon the totality of safety, activity, and PK data.
Full Information
NCT ID
NCT05789082
First Posted
February 21, 2023
Last Updated
September 25, 2023
Sponsor
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT05789082
Brief Title
A Study Evaluating the Safety, Activity, and Pharmacokinetics of GDC-6036 in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Official Title
A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of GDC-6036 in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of GDC-6036 combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Expansion
Arm Type
Experimental
Arm Description
Participants enrolled in this cohort will receive GDC-6036 once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).
Arm Title
Combination Dose Finding + Expansion
Arm Type
Experimental
Arm Description
During the expansion stage, some participants are planned to be randomized to one GDC-6036 combination dose level; other participants are planned to be randomized to another GDC-6036 combination dose level. GDC-6036 will be given in combination with pembrolizumab.
Intervention Type
Drug
Intervention Name(s)
GDC-6036
Intervention Description
Participants will receive one of two doses of GDC-6036 orally (PO), QD on days 1-21 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Baseline until 60 days after the final dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 3 years)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
The percentage of participants who experience a complete response or partial response, as determined by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
Up to approximately 3 years
Title
Duration of Response (DOR)
Description
The time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time Frame
Up to approximately 3 years
Title
Progression Free Survival (PFS)
Description
The time from randomization, or date of first treatment for participants enrolled prior to the expansion stage, to the first occurrence of disease progression or death from any cause during the study (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time Frame
Up to approximately 3 years
Title
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Side Effects as Assessed Through the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame
Up to approximately 3 years
Title
Change from Baseline in Symptomatic Side Effects, as Assessed Through use of the PRO-CTCAE
Time Frame
Baseline up to approximately 3 years
Title
Percentage of Participants Reporting "Frequent" or "Almost Constant" Diarrhea During the First Three Cycles of Treatment According to the PRO-CTCAE Criteria
Time Frame
Up to approximately 3 years
Title
Percentage of Participants Reporting "Severe" or "Very Severe" Nausea or Vomiting During the First Three Cycles of Treatment According to the PRO-CTCAE
Time Frame
Up to approximately 3 years
Title
Frequency of Participant's Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the Single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46)
Time Frame
Up to approximately 3 years
Title
Plasma concentration of GDC-6036 at Specified Timepoints
Time Frame
At Days 1, 8 and 15 of Cycles 1 and 2; Days 1 and 15 of Cycles 3 and 4; Day 1 of every other Cycle after Cycle 5, until treatment discontinuation (up to approximately 3 years). Each cycle is 21 days.
Title
Identification of GDC-6036 Recommended Dose
Description
The recommended dose will be based upon the totality of safety, activity, and PK data.
Time Frame
Up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmation of Biomarker eligibility
Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
No prior systemic treatment for advanced unresectable or metastatic NSCLC
Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Exclusion Criteria:
Known concomitant second oncogenic driver with available targeted treatment
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Prior treatment with a KRAS G12C inhibitor
Known hypersensitivity to any of the components of GDC-6036 or pembrolizumab
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment
History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO44426 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Britanico; Oncologia
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Adventista Belgrano; Oncology
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Concord Repatriation General Hospital; Concord Cancer Centre
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
NKI The Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska University Hospital; Sahlgrenska Clinical Trial unit / Department of Oncology
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital; Internal Medicine
City
North Dist.
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan Uni Hospital; Internal Medicine
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation - Linkou; Chest Dept
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Adana City Hospital, Medical Oncology
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Koc University Hospital; Oncology
City
Istanbul
Country
Turkey
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study Evaluating the Safety, Activity, and Pharmacokinetics of GDC-6036 in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
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