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

Unresectable Stage III NSCLC Clinical Trial

Official title:

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）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982549
• Other study ID #: D4191L00116
• Status: Recruiting
• Phase: Phase 2
• Start date: January 21, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: August 2021
• Source: Shandong Cancer Hospital and Institute
• Contact: Jinming Yu, professor
• Phone: 15553181309
• Email: yujinming[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Unresectable Stage III NSCLC

Intervention

Drug:
• Durvalumab
Durvalumab (intravenous infusion)
• Carboplatin/ Paclitaxel
Carboplatin /Paclitaxel, as per standard of care
• Pemetrexed/ Cisplatin
Pemetrexed / Cisplatin, as per standard of care
• Pemetrexed/ Carboplatin
Pemetrexed / Carboplatin , as per standard of care

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

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events	From the date of enrollment until disease progression,assessed up to 4 years
Primary	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	Progression-free survival (PFS)	Progression-free survival	From date of first dose until the date of objective disease progression or death,assessed up to 4 years
Secondary	Overall Survival (OS)	Overall Survival	From the date of first dose until death due to any cause,assessed up to 4 years
Secondary	Objective response rate(ORR)	Objective response rate	From the date of first dose until the date of objective disease progression or death,assessed up to 4 years
Secondary	Duration of response(DOR)	Duration of response	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
Secondary	Disease control rate(DCR)	Disease control rate	From the date of first dose until 24 weeks.
Secondary	Time to death or distant metastasis(TTDM)	Time to death or distant metastasis	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