Trial Outcomes & Findings for Tremelimumab and Durvalumab With or Without Radiation Therapy in Patients With Relapsed Small Cell Lung Cancer (NCT NCT02701400)
NCT ID: NCT02701400
Last Updated: 2021-06-22
Results Overview
Time from initiation of therapy to objective disease progress or death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From initiation of systemic therapy to first documented disease progression, assessed through study completion, up to 2 years
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
Arm I (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
Durvalumab: Given IV
Tremelimumab: Given IV
|
Arm II (RT, Tremelimumab, Durvalumab)
Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
Durvalumab: Given IV
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tremelimumab and Durvalumab With or Without Radiation Therapy in Patients With Relapsed Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Tremelimumab, Durvalumab)
n=9 Participants
Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
Durvalumab: Given IV
Tremelimumab: Given IV
|
Arm II (RT, Tremelimumab, Durvalumab)
n=9 Participants
Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
Durvalumab: Given IV
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION NA • n=99 Participants
|
66.86 years
STANDARD_DEVIATION NA • n=107 Participants
|
67.76 years
STANDARD_DEVIATION NA • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From initiation of systemic therapy to first documented disease progression, assessed through study completion, up to 2 yearsTime from initiation of therapy to objective disease progress or death
Outcome measures
| Measure |
Arm I (Tremelimumab, Durvalumab)
n=9 Participants
Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
Durvalumab: Given IV
Tremelimumab: Given IV
|
Arm II (RT, Tremelimumab, Durvalumab)
n=9 Participants
Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
Durvalumab: Given IV
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.1 months
Standard Deviation 0
|
3.3 months
Standard Deviation 28.6
|
PRIMARY outcome
Timeframe: After every 2 cycles of treatment (1 cycle = 4 weeks), assessed through study completion, up to 2 yearsDisease response to therapy measured according to RECIST 1.1 criteria
Outcome measures
| Measure |
Arm I (Tremelimumab, Durvalumab)
n=9 Participants
Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
Durvalumab: Given IV
Tremelimumab: Given IV
|
Arm II (RT, Tremelimumab, Durvalumab)
n=9 Participants
Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
Durvalumab: Given IV
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
|
|---|---|---|
|
Objective Response Rate
|
2.76 months
Standard Deviation 3.9
|
2.76 months
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Assessed after every 2 cycles (1 cycle = 4 weeks) on treatment; assessed through study completion, up to 2 yearsDisease response to treatment using immune-related response rate (irRR) criteria
Outcome measures
| Measure |
Arm I (Tremelimumab, Durvalumab)
n=9 Participants
Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
Durvalumab: Given IV
Tremelimumab: Given IV
|
Arm II (RT, Tremelimumab, Durvalumab)
n=9 Participants
Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
Durvalumab: Given IV
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
|
|---|---|---|
|
Immune-related Objective Response Rate
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From randomization until death from any cause, assessed through study completion, up to 2 yearsTime interval from entering the study until death
Outcome measures
| Measure |
Arm I (Tremelimumab, Durvalumab)
n=9 Participants
Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
Durvalumab: Given IV
Tremelimumab: Given IV
|
Arm II (RT, Tremelimumab, Durvalumab)
n=9 Participants
Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
Durvalumab: Given IV
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
|
|---|---|---|
|
Overall Survival
|
2.8 months
Interval 0.8 to 12.4
|
5.7 months
Interval 1.6 to 14.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Result presented for assessment at baseline and the end of cycle 1.Population: All patients with at least 2 paired samples collected at baseline and on-treatment at end of cycle 1
Change in circulating and tumor-infiltrating lymphocytes between baseline and on-treatment samples at the end of Cycle 1. The proportion was calculated as the number of specific lymphocytes subset out of the total number of lymphocytes at baseline compared to the same proportion at the end of cycle 1.
Outcome measures
| Measure |
Arm I (Tremelimumab, Durvalumab)
n=13 lymphocyte subtypes
Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
Durvalumab: Given IV
Tremelimumab: Given IV
|
Arm II (RT, Tremelimumab, Durvalumab)
Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
Durvalumab: Given IV
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
|
|---|---|---|
|
Change From Baseline in the Proportion of Lymphocyte Subset (CD8+ICOS+) Between Baseline and On-Treament (End of Cycle 1)
|
1.399 proportion of CD8+ICOS+ Tcells
Interval 0.03091 to 2.766
|
—
|
Adverse Events
Arm I (Tremelimumab, Durvalumab)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Arm II (RT, Tremelimumab, Durvalumab)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place