Stage IIIC Lung Cancer AJCC V8 / Advanced Lung Non Small Cell Carcinoma / Nab-paclitaxel · Phase 3 Trial

Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

ClinicalTrials.gov · September 4, 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 trial registration for a randomized comparison of carboplatin/nab-paclitaxel/paclitaxel/pemetrexed plus pembrolizumab versus pembrolizumab alone in older adults with stage IIIB-IV non-small-cell lung cancer, with overall survival as the primary endpoint. No results have been posted to the registry; the study is currently recruiting. The trial design is rigorous but the outcome data necessary to evaluate efficacy are not yet available.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8; age from 70 Years. Intervention: Arm B (pembrolizumab, chemotherapy). Compared with: Arm A (pembrolizumab) — Active Comparator. n = 304. 324 sites: United States.

Key findings

Safety

No results are posted in this registry record; efficacy, safety, and all outcome data are unreported.

Who this may help

Once results are available, this trial will directly address whether adding chemotherapy to pembrolizumab improves overall survival in older patients with advanced lung cancer, a population often underrepresented in oncology trials. Clinicians should await publication of the primary analysis before adjusting practice.

Plain-language summary

This is an actively recruiting Phase 3 trial with no results posted; the registry record describes planned design and enrollment only, with no outcome data available for assessment.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Overall survival (OS) (assessed at From randomization to death from any cause, and patients who are alive at the t…)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationAdvanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8; age from 70 Years

Sample size304

InterventionArm B (pembrolizumab, chemotherapy)

ComparatorArm A (pembrolizumab) — Active Comparator

Setting324 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment304

Primary outcome measureOverall survival from randomization to death from any cause, assessed up to 5 years

Study phasePhase 3

Clinical bottom line

Caveats

No results are posted in this registry record; efficacy, safety, and all outcome data are unreported.
Blinding, allocation concealment, and other methodological details are not described in the registry entry.
Recruitment status is active; final enrollment and follow-up duration remain unconfirmed.
Primary outcome follow-up extends to 5 years, but interim analysis timing and stopping rules are not specified.

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 randomized controlled trial design comparing two active arms.

Directness

strong

Hard clinical endpoint (overall survival) directly relevant to patient benefit.

Consistency

insufficient

No results reported; consistency cannot be assessed against other evidence.

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or other bias mitigation details.

Sample adequacy

moderate

Planned enrollment 304 participants; adequacy depends on effect size assumption not stated here.

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 (NCT06096844). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 304 participants (ESTIMATED). Conditions: Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8. Interventions: DRUG: Carboplatin; PROCEDURE: Computed Tomography; PROCEDURE: Magnetic Resonance Imaging; DRUG: Nab-paclitaxel; DRUG: Paclitaxel; BIOLOGICAL: Pembrolizumab; DRUG: Pemetrexed; PROCEDURE: Positron Emission Tomography; OTHER: Questionnaire Administration. Primary outcome measures: Overall survival (OS) , From randomization to death from any cause, and patients who are alive at the time of final analysis will be censored at the last date of contact, assessed up to 5 years. Brief summary: This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

Follow from this

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

Stage IIIC Lung Cancer AJCC V8Advanced Lung Non Small Cell CarcinomaNab-paclitaxelNCT06096844Computed TomographyNational Cancer Institute (NCI)Stage IIIB Lung Cancer AJCC V8CarboplatinMagnetic Resonance Imaging