Metastatic Lung Cancer Clinical Trial
Official title:
A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C mutation
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | December 1, 2026 |
| Est. primary completion date | June 1, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS =1%. - Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS < 50% AND previously completed 4 cycles of standard-of-care platinum based induction chemotherapy with pembrolizumab AND experienced stable disease, partial response, or complete response per investigator's assessment after 4 cycles OR if patients received <4 cycles of a platinum-based induction, was stopped early due to intolerable toxicity - Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS < 50% - Presence of measurable disease per RECIST v1.1 Exclusion Criteria: - All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting - Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was >1 year prior to first dose of study treatment) - Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting - Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment - Active brain metastases |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Local Institution - 017-457 | Barretos | |
| Brazil | Local Institution - 017-442 | Curitiba | |
| Brazil | Local Institution - 017-452 | Fortaleza | |
| Brazil | Local Institution - 017-446 | Ijui | Rio Grande Do Sul |
| Brazil | Local Institution - 017-453 | Itajai | Santa Catarina |
| Brazil | Local Institution - 017-455 | Jau | |
| Brazil | Local Institution - 017-458 | Natal | Rio Grande Do Norte |
| Brazil | Local Institution - 017-454 | Rio De Janeiro | |
| Brazil | Local Institution - 017-456 | Sao Paolo | |
| Chile | Local Institution - 017-697 | Providencia | |
| Chile | Local Institution - 017-696 | Santiago | |
| Chile | Local Institution - 017-698 | Temuco | |
| Chile | Local Institution - 017-695 | Vina Del Mar | Valparaiso |
| France | Institut de Cancerologie de lOuest - Angers | Angers Cedex 02 | |
| France | Centre Francois Baclesse | Caen Cedex 5 | |
| France | Centre Hospitalier Intercommunal de Creteil | Creteil | |
| France | Centre Georges Francois Leclerc | Dijon cedex | |
| France | Hopital Michallon | La Tronche | |
| France | Local Institution - 017-688 | Lille | |
| France | Local Institution - Unk078 | Lyon | |
| France | Institut Paoli-Calmettes | Marseille | |
| France | Local Institution - Unk067 | Marseille | |
| France | Local Institution - 017-200 | Montpellier | |
| France | Hopital Tenon | Paris | |
| France | Local Institution - Unk029 | Paris | |
| France | Local Institution - 017-664 | Paris cedex 05 | |
| France | Local Institution - 017-198 | Saint Herblain | |
| France | Hopital Foch | Suresnes | |
| France | Hopital Larrey | Toulouse cedex 9 | |
| France | Gustave Roussy | Villejuif | |
| Georgia | Local Institution - 017-790 | Batumi | |
| Georgia | Local Institution - 017-789 | Tbilisi | |
| Georgia | Local Institution - 017-791 | Tbilisi | |
| Georgia | Local Institution - 017-792 | Tbilisi | |
| Georgia | Local Institution - 017-793 | Tbilisi | |
| Georgia | Local Institution - 017-794 | Tbilisi | |
| Greece | University General Hospital of Heraklion (PAGNI) | Heraklion | |
| Greece | University General Hospital of Larissa | Larissa | |
| Greece | Metropolitan Hospital | Peiraias | |
| Hungary | Orszagos Koranyi Pulmonologiai Intezet | Budapest | |
| Hungary | Orszagos Onkologiai Intezet | Budapest | |
| Hungary | Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz | Szekesfehervar | |
| Hungary | Reformatus Pulmonologiai Centrum | Torokbalint | |
| Italy | Azienda Ospedaliera San Giuseppe Moscati - Avellino | Avellino | |
| Italy | Local Institution - 017-274 | Aviano | |
| Italy | Ospedale Santo Spirito | Casale Monferrato | |
| Italy | Azienda Ospedaliero - Universitaria Careggi | Firenze | |
| Italy | Local Institution - 017-278 | Milan | |
| Italy | Azienda Ospedaliero - Universitaria San Luigi Gonzaga | Orbassano | |
| Italy | Local Institution - 017-297 | Padova | |
| Italy | Ospedale Santa Maria delle Croci di Ravenna | Ravenna | |
| Italy | Istituto Nazionale Tumori Regina Elena | Roma | |
| Italy | Local Institution - 017-280 | Roma | |
| Malaysia | Local Institution - 017-076 | Kota Bharu | Kelantan |
| Malaysia | Local Institution - 017-073 | Kuala Lumpur | |
| Malaysia | Local Institution - 017-075 | Kuantan | Pahang |
| Malaysia | Local Institution - 017-072 | Putrajaya | |
| Poland | Local Institution - 017-381 | Konin | |
| Poland | Instytut MSF | Lodz | |
| Poland | Med Polonia Sp. z o. o. - Obornicka | Poznan | |
| Poland | Wojskowy Instytut Medyczny | Warsaw | |
| Serbia | Local Institution - 017-690 | Belgrade | |
| Serbia | Local Institution - 017-692 | Belgrade | |
| Serbia | Local Institution - 017-693 | Beograd | |
| Serbia | Local Institution - 017-694 | Kragujevac | |
| Serbia | Local Institution - 017-691 | Sremska Kamenica | |
| Spain | Complejo Hospitalario Universitario A Coruna | A Coruna | |
| Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | |
| Spain | Local Institution - Unk001 | Malaga | |
| Spain | Hospital Son Llatzer | Palma de Mallorca | |
| Spain | Hospital Universitario Son Espases | Palma de Mallorca | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital Clinico Universitario Lozano Blesa | Zaragoza | |
| Switzerland | Local Institution - 017-395 | Geneve | |
| Thailand | Local Institution - 017-132 | Bang Phlat | |
| Thailand | Local Institution - 017-136 | Bangkok | |
| Thailand | Local Institution - 017-135 | Chom Thong | |
| Thailand | Local Institution - 017-137 | Khon Kaen | |
| United States | Local Institution - Unk047 | Anaheim | California |
| United States | Local Institution - Unk025 | Anchorage | Alaska |
| United States | Local Institution - Unk009 | Baltimore | Maryland |
| United States | PeaceHealth St. Joseph Medical Center | Bellingham | Washington |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Local Institution - 017-945 | Bronx | New York |
| United States | Local Institution - Unk039 | Burlington | Massachusetts |
| United States | Local Institution - 017-972 | Chicago | Illinois |
| United States | Local Institution - Unk062 | Chicago | Illinois |
| United States | Cleveland Clinic Main Campus | Cleveland | Ohio |
| United States | Local Institution - Unk056 | Dallas | Texas |
| United States | Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Henry Ford Medical Center - Columbus | Detroit | Michigan |
| United States | Local Institution - Unk069 | Detroit | Michigan |
| United States | Hematology-Oncology Associates of Central New York - Brittonfield - East Syracuse | East Syracuse | New York |
| United States | Local Institution - Unk066 | Fairfax | Virginia |
| United States | Virginia Cancer Specialists - Fairfax Office | Fairfax | Virginia |
| United States | MemorialCare - Orange Coast Medical Center | Fountain Valley | California |
| United States | Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton | Fullerton | California |
| United States | Local Institution - 017-591 | Glendale | Arizona |
| United States | Local Institution - 017-848 | Houston | Texas |
| United States | Local Institution - Unk036 | Huntington | West Virginia |
| United States | Local Institution - 017-999 | Irving | Texas |
| United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
| United States | Local Institution - 017-836 | Kettering | Ohio |
| United States | The Oncology Institute of Hope and Innovation - Lakeland | Lakeland | Florida |
| United States | Local Institution - Unk018 | Lansing | Michigan |
| United States | Local Institution - 017-965 | Lexington | Kentucky |
| United States | Local Institution - Unk004 | Loma Linda | California |
| United States | USOR - Rocky Mountain Cancer Centers - Lone Tree | Lone Tree | Colorado |
| United States | USOR - Texas Oncology Northeast Texas - Longview Cancer Center | Longview | Texas |
| United States | Local Institution - 017-961 | Los Angeles | California |
| United States | Local Institution - 017-916 | Memphis | Tennessee |
| United States | Local Institution - Unk076 | Miami | Florida |
| United States | Local Institution - Unk055 | Orlando | Florida |
| United States | Local Institution - Unk008 | Osage Beach | Missouri |
| United States | Local Institution - 017-821 | Phoenix | Arizona |
| United States | New York Cancer & Blood Specialists - Cancer Center - Research Headquarters | Port Jefferson Station | New York |
| United States | Mayo Clinic - Rochester | Rochester | Minnesota |
| United States | Metro-Minnesota Community Oncology Research Consortium (MMCORC) | Saint Louis Park | Minnesota |
| United States | Local Institution - Unk010 | Salt Lake City | Utah |
| United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
| United States | Local Institution - Unk058 | Springfield | Missouri |
| United States | University of Kansas Cancer Center - Westwood/Richard and Annette Bloch Cancer Care Pavilion | Westwood | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Mirati Therapeutics Inc. |
United States, Brazil, Chile, France, Georgia, Greece, Hungary, Italy, Malaysia, Poland, Serbia, Spain, Switzerland, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) for Cohort A and E | Defined as the percent of patients documented to have a confirmed CR or PR | 30 months | |
| Primary | Progression-free Survival (PFS) at six months for Cohort C | PFS is defined as time from first study treatment until disease progression or death from any cause, whichever occurs first. | 30 months | |
| Secondary | Adverse Events | Defined as number of patients with treatment emergent AEs | 30 months | |
| Secondary | Duration of Response (DOR) | Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first. | 30 months | |
| Secondary | Overall Survival (OS) | Defined as time from date of first study treatment to date of death due to any cause | 30 months | |
| Secondary | Progression-free Survival (PFS) | Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first. | 30 months | |
| Secondary | Population pharmacokinetic (PK) Model Derived AUC at Steady State (AUCtau,ss). | Concentration data from this study will be pooled with other studies and exposure parameters derived using population PK methods. Data for this Outcome Measure will not be reported here since ClinicalTrials.gov is designed to report results from participants enrolled in the study and described in the Participant Flow module. | Time Frame: Pre-dose and 4-6 hours post dose; up to 6 months | |
| Secondary | Cohorts C and E: DLTs during SLI (Safety Lead In) | Defined as those patients in the SLI of the study who have received at least 80% of the assigned dose of adagrasib during the first cycle on study, or interrupted or discontinued study treatment during the first cycle due to a DLT. | 30 months |
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