Amivantamab / Osimertinib / Non Small Cell Lung Cancer (NSCLC) · Phase 2 Trial

A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registration for osimertinib plus amivantamab in EGFR-mutant NSCLC. No results are reported in this registry record; the study is active but not recruiting, with follow-up planned for approximately 52 months. Clinicians should await peer-reviewed publication of outcomes before drawing conclusions about safety or efficacy.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. Non-Small Cell Lung Cancer (NSCLC); age from 18 Years; to 130 Years. Intervention: Osimertinib+Amivantamab. n = 60. 28 sites across 6 countries.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported.

Who this may help

Results from this trial are not yet available. Clinicians should monitor for peer-reviewed publication before considering osimertinib plus amivantamab combinations outside established protocols.

Plain-language summary

Phase 2 interventional trial with planned safety and efficacy endpoints in EGFR-mutant NSCLC; no results reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Number of participants with adverse events (AEs) (assessed at From screening (Day-28) to survival follow up (Approximately 52 months after th…); Progression Free Survival (PFS) (assessed at From date of first dose of study intervention until radiological disease progre…)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationNon-Small Cell Lung Cancer (NSCLC); age from 18 Years; to 130 Years

Sample size60

InterventionOsimertinib+Amivantamab

Setting28 sites across 6 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment60

PhasePhase 2

Primary outcome 1Number of participants with adverse events from screening (Day -28) to approximately 52 months after first dose

Primary outcome 2Progression-free survival from date of first dose until radiological disease progression or death, approximately 52 months follow-up

Clinical bottom line

Results from this trial are not yet available. Clinicians should monitor for peer-reviewed publication before considering osimertinib plus amivantamab combinations outside established protocols.

Caveats

This is a registry record only; no efficacy or safety results are reported.
Single-arm design implied but not explicitly stated in the registry text.
Comparator arm (if any) and randomisation details not specified.
No interim or final efficacy data available in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 design appropriate for safety and efficacy assessment; single-arm implied by registry text.

Directness

strong

Primary endpoints directly address safety and PFS in target population with EGFR mutations.

Consistency

insufficient

Registry record only; no results reported for comparison with other studies.

Risk of bias

insufficient

No results posted; blinding, randomisation, and analysis methods not described.

Sample adequacy

limited

60 planned participants; typical for Phase 2 but modest sample size.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05801029). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ACTUAL). Conditions: Non-Small Cell Lung Cancer (NSCLC). Interventions: DRUG: Osimertinib; DRUG: Amivantamab. Primary outcome measures: Number of participants with adverse events (AEs) , From screening (Day-28) to survival follow up (Approximately 52 months after the first participant is dosed); Progression Free Survival (PFS) , From date of first dose of study intervention until radiological disease progression or death due to any cause (Approximately 52 months after the first participant is dosed). Brief summary: This study will assess the safety and efficacy of Osimertinib with Amivantamab as First-line Treatment in Participants with Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

AmivantamabNCT05801029OsimertinibNon Small Cell Lung Cancer (NSCLC)AstraZeneca