OncoMatch/Clinical Trials/NCT06096844
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Official title: A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study
Is NCT06096844 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments for advanced lung non-small cell carcinoma.
Treatment: Carboplatin · Nab-paclitaxel · Paclitaxel · Pembrolizumab · Pemetrexed — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (TPS 1-49%)
PD-L1 Tumor Proportion Score (TPS) range of 1-49%
Required: EGFR wild-type
tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
Required: ALK wild-type
tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: cytotoxic chemotherapy for metastatic disease
Exception: Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration
Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration
Cannot have received: immunotherapy for metastatic disease
Exception: Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration
Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500/uL; Platelets ≥ 75,000/uL; Hemoglobin (Hgb) ≥ 8.0 g/dL
Kidney function
Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured)
Liver function
Exact limits: see the full eligibility criteria on this page.
Exact limits: see the full eligibility criteria on this page.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Highlands Oncology Group - Fayetteville · Fayetteville, Arkansas
- Mercy Hospital Fort Smith · Fort Smith, Arkansas
- Highlands Oncology Group - Rogers · Rogers, Arkansas
- Highlands Oncology Group · Springdale, Arkansas
- Kaiser Permanente Dublin · Dublin, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06096844 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytotoxic chemotherapy for metastatic disease, immunotherapy for metastatic disease disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify