Clinical trial · Interventional
A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC
A Prospective Study to Evaluate the Safety of Concurrent Durvalumab (MEDI4736) With Chemoradiation Therapy（CRT）Followed by Durvalumab for Chinese Unresectable Stage III Non Small Cell Lung Cancer（NSCLC）
NCT04982549CI-TRIAL-00053141unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Stage III NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin/ Paclitaxel | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Pemetrexed/ Carboplatin | Drug | — | UNRESOLVED |
| Pemetrexed/ Cisplatin | Drug | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab + platinum-based chemotherapy and radiation
- description
- All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.
- interventionNames
- Drug: Durvalumab
- Drug: Carboplatin/ Paclitaxel
- Drug: Pemetrexed/ Cisplatin
- Drug: Pemetrexed/ Carboplatin
- Radiation: Radiation
Primary outcomes (1)
- measure
- Grade ≥3 immune-mediated Adverse event
- timeFrame
- From the date of first dose until disease progression,assessed up to 4 years
- description
- Grade ≥3 immune-mediated Adverse event
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with histologically or cytologically-documented NSCLC * Locally advanced, unresectable (Stage III) NSCLC * World Health Organization (WHO) performance status 0-1 * At least one measurable lesion, not previously irradiated * Must have a life expectancy of at least 12 weeks at randomization * Adequate lung function: Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or \>40% predicted value and DLCO \>30% predicted value * Must provide an archived tumor tissue block(or at least 15 newly cut unstained slides)≤3 years old; if archived sample unavailable then must provide a recent(≤3 months) tumor biopsy. Exclusion Criteria: * Mixed small-cell and NSCLC histology * Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs. * Prior exposure to immune-mediated therapy, including but not limited to, other anti- CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. * Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume * Planned radiation cardiac dose V50\>25% * Any medical contraindication of platinum-based doublet chemotherapy as listed in the local labelling or known allergy/hypersensitivity to investigational product and/or its excipients * History of the following: allogeneic organ transplantation, active or prior autoimmune or inflammatory disorders, another primary malignancy, leptomeningeal carcinomatosis, active primary immunodeficiency * Uncontrolled intercurrent illness or active infection
References
Publications (0)
Data not yet available
No reference posted for this study.