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OncoMatch/Clinical Trials/NCT06276283

DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)

Is NCT06276283 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies DZD9008 plus Bevacizumab for non-small cell lung cancer.

Phase 2RecruitingDizal PharmaceuticalsNCT06276283Data as of May 2026

Treatment: DZD9008 plus BevacizumabThis study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR mutation

Written documentation of EGFR mutations from an accredited local laboratory: Part A is not limited to a specific EGFR mutation, and Part B only includes patients with EGFR Exon20ins.

Required: EGFR Exon20ins

Part B only includes patients with EGFR Exon20ins.

Excluded: EGFR Exon19del

Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).

Excluded: EGFR L858R

Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).

Excluded: EGFR T790M

Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).

Excluded: EGFR G718X

Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).

Excluded: EGFR S768I

Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).

Excluded: EGFR L861Q

Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: EGFR Exon20ins inhibitor (poziotinib, mobocertinib, CLN-081, BDTX-189, aumolertinib, AP-L1898)

Exception: only applicable to Part B

Treatment with poziotinib, mobocertinib (TAK788), CLN-081, BDTX-189, aumolertinib, AP-L1898, and other EGFR Exon20ins inhibitors prior to the first dose of study drug (only applicable to Part B).

Cannot have received: EGFR tyrosine kinase inhibitor (gefitinib, erlotinib, icotinib, osimertinib, afatinib, dacomitinib, ametinib)

Exception: only applicable to Part B and only if patient had an objective response (PR or CR)

Prior treatment with 1st to 3rd generation EGFR-TKIs (e.g., gefitinib, erlotinib, icotinib, osimertinib, afatinib, dacomitinib, and ametinib) and have had an objective response (i.e., PR and CR) (only applicable to Part B).

Cannot have received: systemic therapy

Exception: only applicable to treatment naïve patients in Part B

Prior systemic treatment for locally advanced or metastatic NSCLC (only applicable to treatment naïve patients in Part B)

Cannot have received: EGFR antibody

Exception: within 4 weeks of first dose

Treatment with EGFR, HER2, or VEGFR antibody within 4 weeks of the first dose of study drug.

Cannot have received: HER2 antibody

Exception: within 4 weeks of first dose

Treatment with EGFR, HER2, or VEGFR antibody within 4 weeks of the first dose of study drug.

Cannot have received: VEGFR antibody

Exception: within 4 weeks of first dose

Treatment with EGFR, HER2, or VEGFR antibody within 4 weeks of the first dose of study drug.

Cannot have received: chemotherapy

Exception: within 2 weeks of first dose

Chemotherapy or other anti-tumor therapies within 2 weeks of the first dose of study drug.

Cannot have received: radiotherapy

Exception: within 14 days of first dose or unresolved radiotherapy-related toxicities

Radiotherapy within 14 days of the first dose of study drug or unresolved radiotherapy-related toxicities.

Cannot have received: investigational drug

Exception: within 5 half-lives of the compound

Treatment with an investigational drug within 5 half-lives of the compound.

Lab requirements

Blood counts

Absolute neutrophil count < 1.5 × 10^9/L; Platelet count < 100 ×10^9/L; Hemoglobin < 9 g/dL

Kidney function

Creatinine ≥1.5 × ULN or creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault equation)

Liver function

Total bilirubin >1.5 × ULN if no liver metastases or >3 × ULN in the presence of documented Gilbert's Syndrome or liver metastases; ALT and AST >2.5 × ULN if no demonstrable liver metastases or >5 × ULN in the presence of liver metastases.

Cardiac function

Mean resting corrected QT interval (QTcF) > 470 msec; significant ECG abnormalities; factors that can lead to QTcF prolongation or arrhythmia; evidence of atrial fibrillation (except for drug-related atrial fibrillation that has been resolved after drug discontinuation); evidence of myocardial infarction, congestive heart failure (NYHA Class II or above), and uncontrolled arrhythmia with medication within 6 months of the first dose of study drug.

Inadequate bone marrow reserve or organ function: Absolute neutrophil count < 1.5 × 10^9/L; Platelet count < 100 ×10^9/L; Hemoglobin < 9 g/dL; Total bilirubin >1.5 × ULN if no liver metastases or >3 × ULN in the presence of documented Gilbert's Syndrome or liver metastases; ALT and AST >2.5 × ULN if no demonstrable liver metastases or >5 × ULN in the presence of liver metastases. Creatinine ≥1.5 × ULN or creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault equation); The international normalized ratio > 1.5 × ULN and activated partial thromboplastin time (APTT) > 1.5 × ULN; Serum lipase > 1.5 × ULN and serum amylase > 1.5 × ULN. Cardiac: see exclusion criteria 9.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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