Osimertinib / Cisplatin / Carboplatin · Phase 3 Trial

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

ClinicalTrials.gov · September 9, 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 3 randomised controlled trial comparing osimertinib monotherapy, osimertinib plus chemotherapy, and chemotherapy alone as neoadjuvant treatment in patients with EGFR-mutant resectable non-small-cell lung cancer. The trial is actively recruiting and has not yet posted results; primary outcomes (Major Pathological Response by two methods) are scheduled to be assessed at approximately 12 weeks post-randomisation.

What was studied

Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Non-Small Cell Lung Cancer; age from 18 Years; to 100 Years. Intervention: Arm 2: Osimertinib with platinum-based chemotherapy; Arm 3: Osimertinib monotherapy. Compared with: Arm 1: Placebo with platinum-based chemotherapy — Placebo Comparator. n = 358. 158 sites across 25 countries.

Key findings

Safety

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

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active clinical trial registry record with no posted results; the study design and planned endpoints are documented but outcome data are not yet reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Major Pathological Response (MPR) - IASLC Method (assessed at From date of randomization to an average of 12 weeks after the first dose); Major Pathological Response (MPR) - Chemotherapy Method (assessed at From date of randomization to an average of 12 weeks after the first dose)

DesignPhase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationNon-Small Cell Lung Cancer; age from 18 Years; to 100 Years

Sample size358

InterventionArm 2: Osimertinib with platinum-based chemotherapy; Arm 3: Osimertinib monotherapy

ComparatorArm 1: Placebo with platinum-based chemotherapy — Placebo Comparator

Setting158 sites across 25 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment358

Study phasePhase 3

Primary outcome measure 1Major Pathological Response (MPR) - IASLC Method

Primary outcome measure 2Major Pathological Response (MPR) - Chemotherapy Method

Assessment timepointapproximately 12 weeks after first dose

Caveats

This is a registry record only; no efficacy, safety, or outcome results are reported.
Blinding status, allocation concealment method, and statistical analysis plan are not detailed in this registry entry.
Primary endpoint definitions and response criteria are named but not fully specified in the source text.
Final results and confidence intervals for Major Pathological Response rates are not yet available.

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

strong

Phase 3, randomised, controlled, 3-arm, multi-centre design explicitly stated.

Directness

strong

Primary endpoints are Major Pathological Response, directly relevant to neoadjuvant therapy evaluation.

Consistency

insufficient

No results posted; consistency with other evidence cannot be assessed.

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or outcome adjudication methods.

Sample adequacy

moderate

358 participants enrolled; adequate for Phase 3 but powered sample size not stated in registry.

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 (NCT04351555). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 358 participants (ACTUAL). Conditions: Non-Small Cell Lung Cancer. Interventions: DRUG: Osimertinib; DRUG: Cisplatin; DRUG: Carboplatin; DRUG: Placebo; DRUG: Pemetrexed. Primary outcome measures: Major Pathological Response (MPR) - IASLC Method , From date of randomization to an average of 12 weeks after the first dose; Major Pathological Response (MPR) - Chemotherapy Method , From date of randomization to an average of 12 weeks after the first dose. Brief summary: This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

Follow from this

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

OsimertinibNCT04351555CisplatinCarboplatinAstraZenecaPemetrexedNon Small Cell Lung Cancer