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

ConditionsAdvanced Lung Non-Small Cell CarcinomaStage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age70+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

STEP 1 REGISTRATION

Patient must be ≥ 70 years of age

Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%

Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carboplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Nab-paclitaxel

    Drug

    Given IV

  • Paclitaxel

    Drug

    Given IV

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Pemetrexed

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

304 Participants
are divided into 2 treatment groups
Group A: Arm A (pembrolizumab)Active comparator 5 interventions
Group B: Arm B (pembrolizumab, chemotherapy)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios. Comparison of OS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 0.025. Other comparisons of groups will be made using the log rank test and Cox modeling.

Time frame
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

Secondary outcomes

1

Progression free survival (PFS)

Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios.

Time frame
From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 5 years
2

Six month PFS

Defined as the proportion of patients who remained alive and progression-free at 6 months. Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios.

Time frame
From randomization to documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed at 6 months
3

Best objective response

Will be evaluated via RECIST 1.1 criteria. Best objective response rate is defined as the proportion of patients with measurable disease at baseline achieved complete response (CR) or partial response (PR) as best response from the start of the treatment until disease progression/recurrence or start of non-protocol therapy. Patients who do not start treatment and patients who do not have any follow-up disease evaluation and do not meet RECIST criteria for clinical progression are coded as not evaluable. Patients who are not evaluable are included in the calculation of response rates (as non-responders).

Time frame
Up to 5 years
4

Incidence of adverse events

Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicity will be assessed by summaries by CTCAE grade.

Time frame
Up to 2 years

Other outcomes

1

Gut microbe abundances

Will relate gut microbe abundances to treatment outcomes, toxicity, and geriatric assessments.

Time frame
Baseline and after 4 cycles of initial treatment (Cycles = 21 days)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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