A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC
Phase 2
- Conditions
- Unresectable Stage III NSCLC
- Interventions
- Drug: Carboplatin/ PaclitaxelDrug: Pemetrexed/ CisplatinDrug: Pemetrexed/ CarboplatinRadiation: Radiation
- Registration Number
- NCT04982549
- Lead Sponsor
- Shandong Cancer Hospital and Institute
- Brief Summary
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).
- Detailed Description
Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD）based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Durvalumab + platinum-based chemotherapy and radiation Carboplatin/ Paclitaxel 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. Durvalumab + platinum-based chemotherapy and radiation Pemetrexed/ Cisplatin 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. Durvalumab + platinum-based chemotherapy and radiation Pemetrexed/ Carboplatin 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. Durvalumab + platinum-based chemotherapy and radiation Radiation 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. Durvalumab + platinum-based chemotherapy and radiation Durvalumab 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.
- Primary Outcome Measures
Name Time Method Grade ≥3 immune-mediated Adverse event From the date of first dose until disease progression,assessed up to 4 years Grade ≥3 immune-mediated Adverse event
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From the date of first dose until death due to any cause,assessed up to 4 years Overall Survival
Objective response rate(ORR) From the date of first dose until the date of objective disease progression or death,assessed up to 4 years Objective response rate
Time to death or distant metastasis(TTDM) From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years Time to death or distant metastasis
Duration of response(DOR) From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years Duration of response
Progression-free survival (PFS) From date of first dose until the date of objective disease progression or death,assessed up to 4 years Progression-free survival
Disease control rate(DCR) From the date of first dose until 24 weeks. Disease control rate
Trial Locations
- Locations (2)
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China