Trial Outcomes & Findings for Chemoradiation Followed by Durvalumab in Poor Risk and/or Elderly Patients With Stage III NSCLC (NCT NCT04441138)

Last Updated: 2025-05-28

Results Overview

To determine the percentage of poor risk and/or elderly unresectable stage III NSCLC patients who complete split course chemoradiation. Objective will be assessed as a binary endpoint of yes/no completion for each patient.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

3 months

Results posted on

2025-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
Overall Study STARTED	10
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemoradiation Followed by Durvalumab in Poor Risk and/or Elderly Patients With Stage III NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab n=10 Participants Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants
Age, Continuous	74 years STANDARD_DEVIATION 9.33 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	10 participants n=99 Participants
ECOG-Performance Status	2 units on a scale n=99 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab n=10 Participants Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
Rate of Split Course Chemoradiation Completion	8 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: These patients all completed split course chemoradiation, and had the opportunity to receive Durvalumab

To determine the safety and tolerability of durvalumab (MEDI4736) after completion of chemoradiation in this group of patients. Objective will be measured by (a) the number of cycles of durvalumab received for each treated patient and (b) the binary endpoint of discontinuation of durvalumab.

Outcome measures

Outcome measures
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab n=8 Participants Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
Number of Cycles of Durvalumab (MEDI4736) Received for Each Treated Patient	4 Cycles Standard Deviation 4.96

SECONDARY outcome

Timeframe: 1 year

To determine the 1-year overall survival rate

Outcome measures

Outcome measures
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab n=10 Participants Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
One-year Overall Survival (OS)	8 Participants

SECONDARY outcome

Timeframe: 1 year

To determine the 1-year progression-free survival rate based on the EORTC RECIST 1.1 criteria for solid tumors as follows: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab n=10 Participants Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
One-year Progression-Free Survival (PFS) According to RECIST 1.1	5 Participants

SECONDARY outcome

Timeframe: 1 year

To determine the 1-year loco-regional progression-free survival rate, based on the EORTC RECIST 1.1 criteria for solid tumors as follows: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab n=10 Participants Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
One-Year Loco-regional Progression-free Survival (PFS) According to RECIST 1.1	5 Participants

SECONDARY outcome

Timeframe: 1 year

To determine rate of grade 3 and 4 toxicities with this regimen in the selected patient population

Outcome measures

Outcome measures
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab n=10 Participants Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
Rate of Grade 3 and 4 Toxicities Assessed by CTCAE v 5.0	20 percentage of patients

Adverse Events

Concurrent, Split Course Chemoradiation Followed by Durvalumab

Serious events: 0 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Concurrent, Split Course Chemoradiation Followed by Durvalumab n=10 participants at risk Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer Durvalumab: Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 5/10 • Number of events 7 • 1 year

Additional Information

Dr. Gaurav Marwaha

Rush University Medical Center

Phone: 3129424399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place