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A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS >=50% (KANDLELIT-004)

MK-1084 With Pembrolizumab in 1L NSCLC With KRAS G12C Mutations and PD-L1 >=50%

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Pending

Nov. 01, 2024

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

- Has histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC)
- Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
- Provides an archival tumor tissue sample (<=5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
- If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to <= Grade 1 or baseline
- If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
- If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable

- Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has known history of, or active, neurologic paraneoplastic syndrome
- Has an active infection requiring systemic therapy, with exceptions
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
- Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
- Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has history of allogenic tissue/solid organ transplant
- Has not fully recovered from any effects of major surgical procedure

Both

Non-Small Cell Lung Cancer

Arm A: MK-1084 100 mg every day(qd) po combined with pembrolizumab 200 mg every 3 weeks(q3w) intravenous(IV)
Arm B: Placebo qd po combined with pembrolizumab 200 mg q3w IV

Progression-free survival(PFS): the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
Overall survival (OS): the time from randomization to death due to any cause

- Objective response: complete response(CR) or partial response(PR)
- Duration of response(DOR): For participants who show confirmed CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
- Adverse event(AE)
- Discontinuation from the study due to an AE
- Change in score from baseline in the following patient-reported outcome(PRO) scales/items:
-Global health status/quality of life(QoL) score (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Core version [EORTC QLQ-C30] items 29 and 30)
-Physical functioning score (EORTC QLQ-C30 items 1-5)
-Role functioning score (EORTC QLQ C30 items 6-7)
-Dyspnea score (EORTC QLQ-C30 item 8)
-Cough (European Organisation For Research And Treatment Of Cancer - Quality of Life Questionnaire - Lung Cancer version [EORTC QLQ-LC13] item 31)
-Chest pain (EORTC QLQ-LC13 item 40)

- Time to deterioration in a given scale item from baseline.
Time to deterioration in the following scales/items:
-Global health status/QoL score (EORTC QLQ-C30 items 29 and 30)
-Physical functioning score (EORTC QLQ-C30 items 1-5)
-Role functioning score (EORTC QLQ-C30 items 6-7)
-Dyspnea score (EORTC QLQ-C30 item 8)
-Cough (EORTC QLQ-LC13 item 31)
-Chest pain (EORTC QLQ-LC13 item 40)

+81-3-3822-2131

July. 26, 2024

Yes

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