Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be able to provide documented informed consent.

Aged ≥ 18 years.

Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced or metastatic, not suitable for curative therapy.

Documentation of EGFR mutation from a local certified laboratory. Part A: EGFR mutations (excluding participants only harboring EGFR exon20ins). Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.

Disqualifiers

NSCLC with mixed small-cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.

For part A: participants only harboring EGFR exon20ins(harboring other EGFR mutations could be enrolled).

Prior treatment with any of the following: 1) Previously received two or more than two lines of third-generation EGFR TKI treatment. 2) Previously received systemic anti-cancer therapy for advanced disease (only for B3 cohort). 3) Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 4) Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration; 5) Radiotherapy with a limited field of radiation for palliation within 7 days of the first administration, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first administration; 6) Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration; 7) Currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 2 weeks is required prior to the first study drug administration; 8) Currently receiving or unable to stop drugs known to be proton-pump inhibitors. A washout period of at least 1 week is required prior to the first study drug administration; 9) Major surgery within 4 weeks of the first administration of study drug administration or anticipated during the study period.

Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DZD6008

    Drug

    DZD6008 will be administered orally at 40/60 mg QD or selected dose.

  • Sunvozertinib

    Drug

    Sunvozertinib will be administered orally at 100/200 mg QD or selected dose.

  • Osimertinib

    Drug

    Osimertinib will be administered orally at 80 mg QD

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: DZD6008 + SunvozertinibExperimental treatment 2 interventions
Group B: OsimertinibActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A: To assess safety and tolerability

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

Time frame
Through the study completion, an average of around 2 years
2

Part A: To assess safety and tolerability

Number of participants with Dose-limiting Toxicities (DLTs)

Time frame
21 days after the first dose
3

Part B: To assess anti-tumor activity

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

Time frame
Through the study completion, an average of around 2 years

Secondary outcomes

1

Part A: To assess the anti-tumor activity

ORR assessed by investigator per RECIST version 1.1

Time frame
Through the study completion, an average of around 2 years
2

Part A: To assess the anti-tumor activity

Duration of Response (DoR) assessed by investigator per RECIST version 1.1

Time frame
Through the study completion, an average of around 2 years
3

Part A: To assess the anti-tumor activity

Disease Control Rate (DCR) assessed by investigator per RECIST version 1.1

Time frame
Through the study completion, an average of around 2 years
4

Part A: To assess the anti-tumor activity

Percentage change in tumor size assessed by investigator per RECIST version 1.1

Time frame
Through the study completion, an average of around 2 years

Other outcomes

Sponsors and contacts

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