A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC

NCT04982549 | Unknown Phase 2

• 1 other identifier: D4191L00116
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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).

Conditions

Unresectable Stage III NSCLC

Outcome Measures

Primary Outcomes (1)

• Grade ≥3 immune-mediated Adverse event

  Grade ≥3 immune-mediated Adverse event

  From the date of first dose until disease progression,assessed up to 4 years

Secondary Outcomes (6)

• Progression-free survival (PFS)

  From date of first dose until the date of objective disease progression or death,assessed up to 4 years

• Overall Survival (OS)

  From the date of first dose until death due to any cause,assessed up to 4 years

• Objective response rate(ORR)

  From the date of first dose until the date of objective disease progression or death,assessed up to 4 years

• 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

• Disease control rate(DCR)

  From the date of first dose until 24 weeks.

Other Outcomes (1)

• Adverse events

  From the date of enrollment until disease progression,assessed up to 4 years

Study Arms (1)

Durvalumab + platinum-based chemotherapy and radiation

EXPERIMENTAL

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; Drug: Carboplatin/ Paclitaxel; Drug: Pemetrexed/ Cisplatin; Drug: Pemetrexed/ Carboplatin; Radiation: Radiation

Interventions

Durvalumab DRUG

Durvalumab (intravenous infusion)

Also known as: MEDI4736

Durvalumab + platinum-based chemotherapy and radiation

Carboplatin/ Paclitaxel DRUG

Carboplatin /Paclitaxel, as per standard of care

Durvalumab + platinum-based chemotherapy and radiation

Pemetrexed/ Cisplatin DRUG

Pemetrexed / Cisplatin, as per standard of care

Durvalumab + platinum-based chemotherapy and radiation

Pemetrexed/ Carboplatin DRUG

Pemetrexed / Carboplatin , as per standard of care

Durvalumab + platinum-based chemotherapy and radiation

Radiation RADIATION

5 fractions/ week for \~6 weeks (±3 days) (Total 60 Gy)

Durvalumab + platinum-based chemotherapy and radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (2)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Interventions

durvalumab; CP protocol; Pemetrexed; Cisplatin; Carboplatin; Radiation

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Physical Phenomena

Central Study Contacts

Jinming Yu, professor

CONTACT

15553181309; yujinming@126.com

Feifei Teng, physician

CONTACT

13075305460; tengfeifei16@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: July 29, 2021
• Study Start: January 21, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

CN (2)