A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Durvalumab + platinum-based chemotherapy and 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. |
Drug: Durvalumab
Durvalumab (intravenous infusion)
Other Names:
Drug: Carboplatin/ Paclitaxel
Carboplatin /Paclitaxel, as per standard of care
Drug: Pemetrexed/ Cisplatin
Pemetrexed / Cisplatin, as per standard of care
Drug: Pemetrexed/ Carboplatin
Pemetrexed / Carboplatin , as per standard of care
Radiation: Radiation
5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- Disease control rate(DCR) [From the date of first dose until 24 weeks.]
Disease control 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
Other Outcome Measures
- Adverse events [From the date of enrollment until disease progression,assessed up to 4 years]
Adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects with histologically or cytologically-documented NSCLC
-
Locally advanced, unresectable (Stage III) NSCLC
-
World Health Organization (WHO) performance status 0-1
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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.
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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.
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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
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Planned radiation cardiac dose V50>25%
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Henan Cancer Hospital | Zhengzhou | Henan | China | 450000 |
| 2 | Shanghai Pulmonary Hospital | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Shandong Cancer Hospital and Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D4191L00116