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Trial protocol evaluates induction chemo-immunotherapy plus durvalumab for unresectable locally advanced non-small-cell lung cancerNew trial tests adding immunotherapy to lung cancer treatment

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Key Takeaway
Note that this is a trial protocol; no results are currently available to inform clinical practice.

The study is a Phase III randomized controlled trial designed to evaluate the efficacy of induction chemo-immunotherapy followed by concurrent chemoradiotherapy (cCRT) and durvalumab consolidation in patients with unresectable locally advanced non-small-cell lung cancer (LA-NSCLC). The study population consists of 212 previously untreated patients without activating EGFR mutations.

The intervention group receives induction chemo-immunotherapy followed by cCRT and durvalumab consolidation. The comparator group receives cCRT followed by durvalumab consolidation. The primary outcomes are progression-free and overall survival. Secondary outcomes include objective response rate, the proportion of patients proceeding to cCRT after induction therapy, and adverse events.

No results regarding efficacy or safety are reported as the study is currently in the design and enrollment phase. Specific data on adverse events, discontinuations, or tolerability are not reported. The trial aims to determine if adding induction chemo-immunotherapy improves survival outcomes in this population. Clinical utility is currently limited by the lack of available data.

How this fits prior evidence

How this fits prior evidence: This trial addresses a gap in the management of unresectable LA-NSCLC by investigating an induction chemo-immunotherapy regimen. It relates to the finding that neoadjuvant chemoimmunotherapy shows promising pathologic response and survival in stage II lung cancer. However, this study focuses on unresectable LA-NSCLC rather than stage II disease. No other prior coverage items directly involve induction chemo-immunotherapy for this specific stage of lung cancer.

Living with advanced lung cancer is a heavy burden, and finding the most effective treatment path is vital for patients and their families. A new trial is looking at a specific type of lung cancer called non-small-cell lung cancer that cannot be removed by surgery.

Researchers are testing a new sequence of care. Instead of starting with radiation and chemotherapy, they want to see if adding an immunotherapy drug called durvalumab at the very beginning helps. This initial step, called induction therapy, is designed to see if it improves the chances of survival and slows the growth of the cancer.

Because this is a trial protocol, the study is currently in the design and enrollment phase. This means the researchers have not collected or shared any results yet. The study will involve 212 patients to see if this specific combination of drugs and radiation works better than the current standard of care.

What this means for you:
A new trial is testing if adding durvalumab before radiation improves outcomes for advanced lung cancer.

Common questions

Who is eligible for this lung cancer study?

This study is for patients with unresectable locally advanced non-small-cell lung cancer. Specifically, it is for patients who have not received prior treatment and do not have certain mutations called activating EGFR mutations.

What is the new treatment being tested?

The trial compares two methods. One group receives induction chemo-immunotherapy followed by radiation and chemotherapy. The other group receives radiation and chemotherapy followed by the drug durvalumab.

Are there any results from this study yet?

No, results are not available yet. Because this is a trial protocol, the study is currently in the design and enrollment phase. No data on survival or side effects has been reported.

Study Details

Study typeRct
Sample sizen = 212
EvidenceLevel 2
Follow-up60.0 mo
PublishedNov 2026
View Original Abstract ↓
BACKGROUND: Definitive concurrent chemoradiotherapy (cCRT) followed by durvalumab consolidation is the current standard of care for unresectable locally advanced non-small-cell lung cancer (LA-NSCLC). However, survival outcomes in this setting remain unsatisfactory. Although the PACIFIC trial improved outcomes, further intensification of systemic therapy may be required to improve long-term survival. Preclinical and perioperative clinical evidence suggests that introducing immunotherapy in the presence of an intact primary tumor may enhance antitumor immune responses. Recently, early-phase studies have reported the feasibility and potential efficacy of induction chemo-immunotherapy followed by cCRT; however, its clinical benefit has not been confirmed in a phase III trial. PATIENTS AND METHODS: This multicenter, randomized, phase III trial is designed to determine whether the addition of induction chemo-immunotherapy to the current standard strategy of cCRT followed by durvalumab consolidation improves survival outcomes in patients with unresectable LA-NSCLC. Previously untreated patients with unresectable LA-NSCLC without activating EGFR mutations are randomized 1:1 to receive either cCRT followed by durvalumab consolidation or induction chemo-immunotherapy followed by cCRT and durvalumab consolidation. Randomization is adjusted for age, clinical stage, programmed death-ligand 1 expression, and institution. The primary endpoints are progression-free and overall survival. Secondary endpoints include objective response rate, proportion of patients proceeding to cCRT after induction therapy, and adverse events. A total of 212 patients will be enrolled from 60 institutions over 5 years. CONCLUSION: The results of this trial should clarify whether the addition of induction chemo-immunotherapy can enhance curative potential and lead to improved overall survival in patients with unresectable LA-NSCLC.
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