{
  "abstract": "Introduction\n\nGarsorasib (D-1553) is an orally administered selective KRAS G12C inhibitor. We report results from group 1 of the phase 1b D1553-101 study assessing garsorasib plus pembrolizumab and platinum-based chemotherapy in participants with KRAS G12C-mutated advanced or metastatic NSCLC.Methods\n\nEligible participants had locally advanced or metastatic NSCLC with KRAS G12C mutation and were candidates for pembrolizumab plus platinum-based chemotherapy. Participants received garsorasib 600 mg once daily or twice daily combined with pembrolizumab 200 mg once every 3 weeks plus 4 to 6 cycles of cisplatin or carboplatin and pemetrexed (nonsquamous histology) or carboplatin and paclitaxel (squamous histology). The primary end points were safety and the incidence of dose-limiting toxicities (DLTs).Results\n\nAs of February 24, 2024, 17 participants received garsorasib 600 mg once daily (n = 10) or twice daily (n = 7) combined with pembrolizumab plus platinum-based chemotherapy. Overall, 94% of participants experienced grade 3 or higher treatment-related adverse events (AEs), and 88% had a dose reduction or interruption due to treatment-related AEs. One participant in the twice-daily group experienced a DLT of grade 2 diarrhea; no other DLTs occurred. Among all participants, the objective response rate was 59%, and the median progression-free survival was 7.4 months.Conclusion\n\nIn participants with KRAS G12C-mutated locally advanced or metastatic NSCLC, despite an encouraging signal of efficacy, the incidence of treatment-related AEs with garsorasib plus pembrolizumab and platinum-based chemotherapy was high, and participants frequently had dose modifications or interruptions due to treatment-related AEs. Based on these findings, the study did not proceed to phase 2.Clinicaltrialsgov identifier\n\nNCT04585035.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing, People's Republic of China.",
    "Department of Oncology, Wuxi People's Hospital, Nanjing Medical University, Wuxi, People's Republic of China.",
    "Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Henan, People's Republic of China.",
    "Department of Medical Oncology, St. Vincent's Hospital, Melbourne, VIC, Australia; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.",
    "Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.",
    "Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon.",
    "Division of Hematology/Oncology, Department of Internal Medicine, Henry Ford Hospital, Detroit, Michigan.",
    "Linear Clinical Research, Ltd., and School of Medicine, University of Western Australia, Perth, West Australia, Australia.",
    "InventisBio Co., Ltd., Shanghai, People's Republic of China.",
    "Merck & Co., Inc., Rahway, NJ, USA."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 13,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Dong Yan"
    },
    {
      "affs": [
        1
      ],
      "name": "Chaoying Liu"
    },
    {
      "affs": [
        2
      ],
      "name": "Xingya Li"
    },
    {
      "affs": [
        3
      ],
      "name": "Melissa Moore"
    },
    {
      "affs": [
        4
      ],
      "name": "Ruihua Xu"
    },
    {
      "affs": [
        5
      ],
      "name": "Rachel E Sanborn"
    },
    {
      "affs": [
        6
      ],
      "name": "Shirish M Gadgeel"
    },
    {
      "affs": [
        7
      ],
      "name": "Michael Millward"
    },
    {
      "affs": [
        8
      ],
      "name": "Zhe Shi"
    },
    {
      "affs": [
        8
      ],
      "name": "Yaolin Wang"
    },
    {
      "affs": [
        8
      ],
      "name": "Kathryn Stazzone"
    },
    {
      "affs": [
        9
      ],
      "name": "Michael J Chisamore"
    },
    {
      "affs": [
        8
      ],
      "name": "Ling Zhang"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/08g2897es1ca2.bib",
  "cited_by": 0,
  "doi": "10.1016/j.jtocrr.2026.101037",
  "fulltext_url": "https://europepmc.org/articles/PMC13689614",
  "id": "08g2897es1ca2",
  "issns": [
    "2666-3643"
  ],
  "landing_url": "https://europepmc.org/article/MED/42924167",
  "language": "eng",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2740|Lung Cancer Treatments and Mutations"
    ]
  ],
  "openalex": "W7166643772",
  "pdf_url": "https://europepmc.org/articles/PMC13689614?pdf=render",
  "pmcid": "PMC13689614",
  "pmid": "42924167",
  "published": "2026-06-30",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/08g2897es1ca2.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:21:02Z",
      "native_id": "MED:42924167",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42924167"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "journal-openalex:2730|Lung Cancer Research Studies",
      "subfield": "oncology"
    }
  ],
  "title": "Garsorasib (D-1553) in Combination With Pembrolizumab and Chemotherapy for First-Line Metastatic NSCLC With KRAS G12C Mutation: Results of a Phase 1b Study.",
  "title_text": "Garsorasib (D-1553) in Combination With Pembrolizumab and Chemotherapy for First-Line Metastatic NSCLC With KRAS G12C Mutation: Results of a Phase 1b Study.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:21:02Z",
  "url": "https://research.draconitic.com/paper/08g2897es1ca2",
  "venue": "JTO clinical and research reports",
  "versions": []
}