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Clinical Trials List

Protocol NumberRMC-LUNG-101D
Active

2025-10-01 - 2027-08-31

Phase II

Not yet recruiting5

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 2, Open-Label, Multicenter Study of Zoldonrasib (RMC-9805) in Previously Treated Patients with RAS G12D-Mutant Non-Small Cell Lung Cancer (NSCLC) – Subprotocol D

  • Sponsor

    Takeda Development Center Americas, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chih-Jen Yang Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chao-Hua Chiu
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

RAS G12D-Mutant Non-Small Cell Lung Cancer (NSCLC) – Subprotocol D

Objectives

• To evaluate the ORR as assessed by RECIST v1.1 criteria of zoldonrasib monotherapy in patients with RAS G12D-mutant NSCLC who have been previously treated with systemic therapy

Test Drug

tablets

Active Ingredient

Zoldonrasib

Dosage Form

110

Dosage

300 mg

Endpoints

• Confirmed ORR per RECIST v1.1 as
assessed by BICR

Inclution Criteria

Patient Characteristics

1. Age: ≥ 18 years of age and informed consent provided. If the legal age of consent for participation in the trial is > 18 years under local regulations, then local regulations shall prevail.

2. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, with no significant decline within 2 weeks after screening. If performance status > 1 for any reason before Day 1 of Cycle 1 (C1D1), rescreening is required.

Disease Characteristics

3. Prior Therapy: Prior therapy must include anti-PD-1 (anti-PD-1)/anti-PD-1 ligand 1 [anti-PD-(L)1] therapy (unless contraindicated) and platinum-based doublet therapy.

4. Mutation Status: A previously confirmed RAS G12D mutation (independent of this trial), determined by DNA sequencing or polymerase chain reaction (PCR) of tumor tissue (within a maximum of 5 years prior to informed consent), and performed in a laboratory with Clinical Laboratory Improvement Amendments (CLIA) accreditation (USA) or equivalent, in accordance with local regulations.

5. Adequate Bone Marrow Function: Hematological criteria must be met without the use of hematopoietic growth factors. For short-acting growth factors, no hematopoietic growth factors must have been used for 7 days prior to the screening laboratory test; for long-acting growth factors, no hematopoietic growth factors must have been used for 14 days prior to screening (i.e., terminal elimination half-life > 48 hours [e.g., pegfilgrastim]).

a. Absolute neutrophil count ≥ 1.5 × 10⁹/L

b. Heme ≥ 9.0 g/dL (no blood transfusion within 2 weeks prior to screening)

c. Platelet count ≥ 100 × 10⁹/L (no blood transfusion within 2 weeks prior to screening)

6. Adequate renal function: Estimated glomerular filtration rate ≥ 60 mL/min, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula or other formula conforming to institutional guidelines, or determined using a 24-hour urine sample.

7. Adequate liver function:

a. Aspartate transaminase and alanine transaminase ≤ 2.5 times the upper limit of normal (ULN).

b. Serum or plasma bilirubin ≤ 1.5 times the ULN or < 2 times the ULN (for patients with Gilbert's syndrome).

(For detailed inclusion and exclusion criteria, please contact the testing physician.)

Exclusion Criteria

Disease Characteristics

1. Untreated Central Nervous System (CNS) Metastases or Meningeal Disease: Patients with treated CNS metastases are eligible for inclusion if they meet all of the following criteria:

a. Radiation therapy completed ≥ 2 weeks prior to C1D1.

b. No evidence of clinical or radiographic worsening on central nervous system imaging performed within 4 weeks prior to C1D1.

c. Stable residual neurological symptoms, Common Adverse Event Evaluation Criteria in Phytosanitary Care Medicine (CTCAE v5.0) grade ≤ 2, and receiving stable doses of steroids and/or antiepileptic therapy (if applicable) ≥ 2 weeks prior to C1D1.

Medical Diseases

2. Severe Lung Disease: History of interstitial pneumonia, pneumonia, pulmonary fibrosis, or radiation-induced pneumonia within 2 months prior to C1D1, or screening imaging evidence of inflamed or worsening interstitial lung disease.

3. Impaired gastrointestinal function: Any condition that may affect the ability to receive or absorb the treatment in the trial (e.g., refractory nausea and vomiting, malabsorption, extensive bowel resection, or poorly controlled inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis).

Other exclusion criteria

4. Major surgery: < 4 weeks prior to C1D1.

(For detailed inclusion and exclusion criteria, please contact the trial physician.)

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    100 participants

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