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Protocol NumberCO45042
Active

2025-08-01 - 2031-12-31

Phase III

Recruiting7

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB AND PEMBROLIZUMAB VERSUS PEMBROLIZUMAB AND PEMETREXED AND CARBOPLATIN OR CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED, KRAS G12C-MUTATED, ADVANCED OR METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

  • Trial Applicant

  • Sponsor

    F. Hoffmann-La Roche Ltd

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NON−SMALL CELL LUNG CANCER

Objectives

To evaluate the efficacy of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin

Test Drug

Injection

Active Ingredient

divarasib
1013005400
1004002410
1012002100
1004001500

Dosage Form

116
270
243
270
270

Dosage

50 mg, 100 mg, 200 mg, 400 mg
100mg/4 mL
500 mg/ 20ml
50mg/50ml, 100mg/100ml
450mg/45ml

Endpoints

• Population: individuals with previously untreated,
KRAS G12C-mutated, advanced or metastatic
non-squamous NSCLC
• Endpoint: PFS, defined as the time from randomization
to disease progression, as determined by BICR
according to RECIST v1.1, or death from any cause
(whichever occurs first)
• Treatment:
– Experimental arm: divarasib and pembrolizumab
o Divarasib: 400 mg PO QD
o Pembrolizumab: 200 mg by IV infusion on
Day 1 of each 21-day cycle for a maximum of
24 months
– Control arm: pembrolizumab and pemetrexed and
investigator's choice of carboplatin or cisplatin
o Pembrolizumab: 200 mg by IV infusion on
Day 1 of each 21-day cycle for a maximum of
24 months
o Pemetrexed: 500 mg/m2 by IV infusion on Day 1
of each 21-day cycle
o Carboplatin AUC 5 or cisplatin 75 mg/m2 by IV
infusion on Day 1 of each 21-day cycle for four
cycles
• Intercurrent events and handling strategies:
– Early discontinuation from study treatment:
treatment policy strategy
– Receipt of non-protocol anti-cancer therapy prior to
disease progression or death: treatment policy
strategy

Inclution Criteria

Potential participants are eligible to be included in the study only if all of the following
criteria apply:
• Signed Informed Consent Form
• Age ≥ 18 years at the time of signing Informed Consent Form
• Ability to comply with the study protocol, in the investigator's judgment
• ECOG Performance Status of 0 or 1, with assessment scale provided in Section 21
• Life expectancy of at least 12 weeks
• Histologically or cytologically confirmed diagnosis of advanced or metastatic
non-squamous NSCLC that is not eligible for curative surgery and/or definitive
chemoradiotherapy
If predominant squamous histology is present for mixed tumors, or components
of small-cell or large-cell neuroendocrine cells are present, then the individual is
ineligible.
• Measurable disease, as defined by RECIST v1.1
Previously irradiated lesions can only be considered measurable disease if
disease progression has been unequivocally documented at that site since
radiation and meet the definition of measurable lesion per RECIST v1.1 and
the previously irradiated lesion is not the only site of measurable disease.
• No prior systemic treatment for advanced or metastatic NSCLC
• Individuals who have received prior neoadjuvant, adjuvant, or perioperative therapy,
or chemoradiotherapy followed by consolidation therapy with curative intent for
non-metastatic disease must have experienced a treatment-free interval of at least
12 months from study enrollment since the last dose of systemic therapy and/or
radiotherapy.
• Documentation of the presence of a KRAS G12C mutation either through central
laboratory testing of a tumor tissue sample (as per local IVD regulations), or
preexisting test results of a blood or tumor tissue sample.
Preexisting test results in blood or tumor tissue for the KRAS G12C mutation
must be available using a validated PCR or next-generation sequencing assay
from an appropriately accredited/certified laboratory (e.g., Clinical Laboratory
Improvement Amendments [CLIA]-certified laboratory). The full legible and
deidentified laboratory report of the KRAS G12C mutation result must be
available and submitted to the Sponsor's designated central laboratory.
Individuals without available preexisting test results for KRAS G12C mutation
status must submit a tumor tissue sample at the time of screening or optional
prescreening for central assessment of biomarker eligibility, as per local IVD
regulations. See Section 8.7 for details on tumor tissue requirements.
• Documentation of PD-L1 expression status in tumor tissue through central laboratory
testing (Agilent/Dako PD-L1 IHC 22C3) or preexisting test results using the Agilent/Dako
PD-L1 IHC 22C3 pharmDx assay (preferred) or the Ventana PD-L1 SP263 IHC assay (if
the patients have been previously assessed with this test as part of standard-of-care
practices).
Preexisting PD-L1 test results must have been obtained using the Agilent/Dako
PD-L1 IHC 22C3 assay (preferred) or the Ventana PD-L1 SP263 IHC assay in
an appropriately accredited or certified laboratory (e.g., CLIA-certified
laboratory). The full legible and de-identified laboratory report of the PD-L1
result must be available and submitted to the Sponsor's designated central
laboratory. Should PD-L1 IHC results exist for both assays, preference should
be given to the Agilent/Dako PD-L1 IHC 22C3 assay. No other PD-L1 assays
are permitted.
Individuals without available preexisting test results for PD-L1 IHC
(Agilent/Dako 22C3 or Ventana SP263) status must submit a tumor tissue
sample at the time of screening or optional prescreening for central PD-L1
assessment. See Section 8.7 for details on tumor tissue requirements.
• Availability of a representative tumor specimen in formalin-fixed, paraffin-embedded
(FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides with an
associated pathology report.
For participants with preexisting results for both KRAS G12C mutation status
and PD-L1 expression, if 15 slides are not available, an absolute minimum of
13 unstained, freshly cut, serial slides may be submitted. The mandatory
tumor tissue sample must be confirmed available during screening and shipped
to the central laboratory within 30 days after randomization. See Section 8.7
for details on tumor tissue requirements.
For individuals who do not have a preexisting test result, the mandatory tumor
tissue sample must be submitted during screening or optional prescreening for
central biomarker testing, as per local IVD regulations.
If archival tumor tissue is unavailable or determined to be unsuitable for
required testing, participants may undergo a biopsy at prescreening or
screening if the investigator deems it safe and clinically feasible. Refer to
Section 8.7 for additional information on collection and analysis of screening
samples.

Exclusion Criteria

Potential participants are excluded from the study if any of the following criteria apply.
Exclusion Criteria Related to NSCLC
• Known concomitant second oncogenic driver with available targeted treatment
(including, but not exclusively limited to, EGFR mutations, ALK rearrangement,
ROS1 rearrangement, BRAFV600E mutation, NTRK fusions, RET fusions,
MET exon 14 skipping mutations)
Testing for listed mutations is not required to determine eligibility, unless
explicitly required by local authorities
• Symptomatic, untreated, or actively progressing CNS metastases
Asymptomatic individuals with treated CNS lesions are eligible, provided that all
of the following criteria are met:
– Measurable disease, per RECIST v1.1, must be present outside the CNS.
– The individual has no history of intracranial hemorrhage or spinal cord
hemorrhage.
– The individual has not undergone stereotactic radiotherapy within 7 days
prior to randomization, whole-brain radiotherapy within 14 days prior to
randomization, or neurosurgical resection within 28 days prior to
randomization.
– The individual has no ongoing requirement for corticosteroids as therapy
for CNS disease.
– If the individual is receiving anti-convulsant therapy, the dose is considered
stable.
– Metastases are limited to the cerebellum or the supratentorial region
(i.e., no metastases to the midbrain, pons, medulla, or spinal cord).
– There is no evidence of interim progression between completion of
CNS-directed therapy and randomization.
– Asymptomatic individuals with CNS metastases newly detected at
screening are eligible for the study after receiving radiotherapy or surgery,
with no need to repeat the screening brain scan.
• Spinal cord compression not definitively treated with surgery and/or radiation or
previously diagnosed and treated spinal cord compression without evidence that
disease has been clinically stable for ≥ 2 weeks prior to randomization
• History of leptomeningeal disease
• Uncontrolled tumor-related pain
Individuals requiring pain medication must be on a stable regimen at
study entry.
Symptomatic lesions amenable to palliative radiotherapy (e.g., bone
metastases or metastases causing nerve impingement) should be treated prior
to randomization. Individuals should be recovered from the effects of radiation.
Asymptomatic metastatic lesions that would likely cause functional deficits or
intractable pain with further growth (e.g., epidural metastasis that is not
currently associated with spinal cord compression) should be considered for
locoregional therapy, if appropriate, prior to enrollment.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (once a month or more frequently)
Individuals with indwelling catheters (e.g., PleurX) are allowed.

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    600 participants

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