Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)

Required: EGFR exon 19 deletion

Tumor positive for Ex19del or L858R EGFR mutation assessed according to local standard.

Required: EGFR L858R

Tumor positive for Ex19del or L858R EGFR mutation assessed according to local standard.

Required: EGFR ex19del or L858R ctDNA detected 21 to 28 days after osimertinib initiation

Persistent mEGFR ctDNA signal 21 to 28 days after osimertinib initiation for advanced of metastatic ex19del or L858R EGFR mutation positive NSCLC as assessed by a liquid biopsy during the pre-screening phase of the trial in the central laboratory.

Must have received: EGFR tyrosine kinase inhibitor (osimertinib) — first-line

Planned treatment with osimertinib 80mg/d 1st-line as SoC or ongoing treatment for a maximum of 28 days

Cannot have received: systemic treatment for advanced or metastatic disease

Exception: osimertinib for a maximum of 28 days

Previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease, except for osimertinib for a maximum of 28 days

Cannot have received: chemotherapy, biologic, or hormonal therapy for cancer

Exception: hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable

Any chemotherapy, biologic, or hormonal therapy for cancer treatment used concurrently or within 6 months prior to first dose of study treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.

Cannot have received: investigational drug

Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.