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OncoMatch/Clinical Trials/NCT06096844

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

Is NCT06096844 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for advanced lung non-small cell carcinoma.

Phase 3RecruitingNational Cancer Institute (NCI)NCT06096844Data as of May 2026

Treatment: Carboplatin · Nab-paclitaxel · Paclitaxel · Pembrolizumab · PemetrexedThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) Tumor Proportion Score (TPS) range of 1-49% (1-49%)

PD-L1 Tumor Proportion Score (TPS) range of 1-49%

Required: EGFR wild-type

tumor that is negative for EGFR mutation

Required: ALK wild-type

tumor that is negative for ... ALK translocations

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 2–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: cytotoxic chemotherapy

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

Cannot have received: immunotherapy

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

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

Total bilirubin  1.5 x institutional upper limit of normal (ULN); AST and ALT  3.0 d7 institutional ULN

ANC  1,500/uL; Platelets  75,000/uL; Hemoglobin (Hgb)  8.0 g/dL; Total bilirubin  1.5 x institutional ULN; AST and ALT  3.0 d7 institutional ULN; Creatinine clearance (CrCL)  45 mL/min

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 →

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