A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)

Required: EGFR exon 19 deletion

EGFR sensitizing mutations (Exon19del and/or L858R) are required

Required: EGFR L858R

EGFR sensitizing mutations (Exon19del and/or L858R) are required

Excluded: EGFR G719X

Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B) [excluded]

Excluded: EGFR S768I

Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B) [excluded]

Excluded: EGFR L861Q

Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B) [excluded]

Excluded: EGFR exon 20 insertion

Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B) [excluded]

Allowed: EGFR T790M

Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B) [excluded]

Allowed: EGFR C797X

Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B) [excluded]

Must have received: EGFR tyrosine kinase inhibitor

Failed (progressed or are intolerant) from at least 1 prior EGFR TKI regimen. Cohort A of Part B: Failed 1 prior third-generation EGFR TKI regimen. Cohorts B of Part B: Patients who are treatment naïve.

Cannot have received: immunotherapy or other antibody therapy

Prior treatment with any of the following: 1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration

Cannot have received: cytotoxic chemotherapy

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

Cannot have received: radiation therapy

Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening

Cannot have received: major surgery

major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period