DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)

NCT07070440 | Recruiting Phase 1

• 1 other identifier: DZ2024C0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate safety and antitumor activity of DZD6008 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants with Dose-limiting Toxicities (DLTs)

  To assess safety and tolerability

  21 days after the first dosing

• Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)

  To assess safety and tolerability

  Through the study completion, an average of around 1 year.

• Objective Response Rate (ORR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  To assess anti-tumor activity

  Through the study completion, an average of around 1 year.

Secondary Outcomes (7)

• Duration of Response(DoR)

  Through the study completion, an average of around 1 year.]

• Disease Control Rate (DCR)

  Through the study completion, an average of around 1 year.

• Progression Free survival (PFS)

  Through the study completion, an average of around 1 year.

• Maximum Plasma/Serum Concentration (Cmax) of DZD6008

  Plasma samples were collected on day 1 of cycle 1, 2, 3, 5, 7, and 9, each cycle is 21 days

• Time to Maximum Plasma/Serum Concentration (Tmax) of DZD6008

  Plasma samples were collected at cycle on day 1 of 1, 2, 3, 5, 7, and 9 , each cycle is 21 days

Study Arms (2)

DZD6008+pemetrexed/carboplatin

EXPERIMENTAL

DZD6008 was administered at 40/60/90 mg Once Daily (QD). Pemetrexed 500 mg/m2, once every 3 weeks, intravenous infusion. Carboplatin AUC 5 mg/mL/min, once every 3 weeks, intravenous infusion

Drug: DZD6008; Drug: Pemetrexed; Drug: Carboplatin

DZD6008+docetaxel

EXPERIMENTAL

DZD6008 was administered at 40/60/90 mg QD. Docetaxel 75 mg/m2, once every 3 weeks, intravenous infusion

Drug: DZD6008; Drug: Docetaxel

Interventions

DZD6008 DRUG

DZD6008 was administered orally at 40/60/90 mg QD.

DZD6008+docetaxel; DZD6008+pemetrexed/carboplatin

Pemetrexed DRUG

Pemetrexed 500 mg/m2, every 3 weeks, intravenous infusion.

DZD6008+pemetrexed/carboplatin

Carboplatin DRUG

Carboplatin AUC 5 mg/mL/min, every 3 weeks, intravenous infusion.

DZD6008+pemetrexed/carboplatin

Docetaxel DRUG

Docetaxel 75 mg/m2, every 3 weeks, intravenous infusion.

DZD6008+docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Age ≥18 years old.
• Locally advanced or metastatic non-squamous non-small cell lung cancer by histopathology or cytology, not suitable for other radical treatment.
• Documentation of EGFR sensitizing mutation confirmed by local laboratory.
• Provide sufficient tumor tissue samples and plasma samples for retrospective analysis of EGFR mutations by central laboratory.
• Failure of prior 3 generations EGFR TKI.
• ECOG status score 0-1, life expectancy ≥12 weeks.
• No central nervous system symptoms during screening, no need for corticosteroids or dehydration diuretic treatment for at least 4 weeks before the first dosing. If the patient with brain metastasis has received radiotherapy or surgery, there is a washout period of ≥2 weeks before the first use of DZD6008 and ensure that the AE related to radiotherapy or surgery has recovered to ≤ 1 grade.
• Presence of measurable lesions defined by RECIST 1.1.
• Sufficient bone marrow or other organ reserve before first dosing.

You may not qualify if:

• Histology mixed with small cell lung cancer (SCLC) or with SCLC transformation.
• Received the following treatments or had the following lifestyle habits, etc.:
• Received immunotherapy or other antibody treatments (including EGFR-targeted antibodies, bispecific antibodies or antibody-drug conjugates, etc.) within 4 weeks before the first study drug administration.
• Received any cytotoxic chemotherapy, study drugs or other anti-cancer drugs (excluding macromolecule drugs) within 14 days before the first study drug administration.
• Received limited-range radiotherapy to relieve the disease within 7 days before the first study drug administration, or received more than 30% of the bone marrow radiotherapy or received wide-range radiotherapy within 28 days before the first medication.
• weeks (for CYP3A4 inhibitors) or 3 weeks (for CYP3A4 inducers) before the first study drug administration, are taking or cannot stop taking known cytochrome P450 (CYP) 3A4 strong inhibitors or inducers (including herbal supplements, such as St. John's wort).
• weeks before the first study drug administration, are taking or cannot stop taking known CYP3A4 sensitive substrate drugs (with a narrow therapeutic window).
• Taking or being unable to stop taking drugs known to be proton pump inhibitors within 1 week before the first study drug administration.
• Major invasive surgery has been performed within 4 weeks before the first study drug administration or is planned during treatment.
• Presence of AEs of ≥1 grade (except any degree of alopecia) caused by previous treatment (such as adjuvant chemotherapy, radiotherapy).
• Tumor-related spinal cord compression or meningeal metastasis.
• History of malignant tumor within 2 years (except for basal cell carcinoma of the skin or cervical cancer in situ that has been adequately treated; other tumors that have been tumor-free for more than 2 years and are expected to survive for more than 2 years, which needs to be discussed with Dizal clinical research physicians).
• Presence of severe or uncontrollable systemic diseases, including poorly controlled hypertension, bleeding diseases.
• Presence of persistent or active infections, including but not limited to hepatitis B, hepatitis C and human immunodeficiency virus infection (HIV).
• Any of the following heart-related diseases or abnormalities:

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Lu

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanli Dong

CONTACT

+86 21 61095854; yuanli.dong@dizalpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 17, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)