Trial Outcomes & Findings for Induction Chemo-Nivo in Unresectable Stage III NSCLC (NCT NCT06003075)
NCT ID: NCT06003075
Last Updated: 2025-04-30
Results Overview
post induction radiographic response by cat scan
TERMINATED
PHASE2
1 participants
9 weeks
2025-04-30
Participant Flow
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Participant milestones
| Measure |
Combination Chemotherapy and Nivolumab and Surgery
Patients with lung cancer receiving combination therapy with surgery
Nivolumab and Chemotherapy: 3 cycles of proposed nivolumab + platinum doublet (either pemetrexed + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for non squamous; or gemcitabine + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for squamous) administered then CT + biopsy, followed by surgery with option for post-op NIVO-XRT, then 12 cycles NIVO at 480 mg IV every 4 weeks for 12 weeks
Nivolumab: Participants receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation
Post Induction Surgery: Induction Chemo-NIVO x 3 cycles then CT + biopsy, followed by surgery in patients with unresectable stage IIIA-C tumors at baseline on the basis of lymphadenopathy and determined to be resectable after responding to induction chemotherapy-nivolumab. participants have an option for post op XRT, then NIVO at 480 mg IV every 4 weeks for 12 cycles
Post Induction XRT: Induction Chemo-NIVO x 3 cycles then CT and biopsy, followed by concurrent Chemo and Nivo XRT (60Gy). Participants will receive concurrent thoracic radiation therapy using a standardized 3DCRT or IMRT technique on a linear accelerator operating at 2:6 MV beam energy. The target total dose of thoracic radiation therapy will be 60 Gy in 30 daily fractions of 2 Gy prescribed to the PTV. Participants then receive NIVO at 480 mg IV every 4 weeks for 12 cycles.
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Combination Chemotherapy and Nivolumab and Radiation
Patients with lung cancer receiving combination therapy with radiation
Nivolumab and Chemotherapy: 3 cycles of the proposed nivolumab + platinum doublet (either pemetrexed + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for non squamous; or gemcitabine + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for squamous) will be administered then CT and biopsy, followed by surgery with option for post-op NIVO-XRT, then 12 cycles NIVO at 480 mg IV every 4 weeks for 12 weeks
Nivolumab: Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation
Post Induction XRT: Induction Chemo-NIVO x 3 cycles then CT and biopsy, followed by concurrent Chemo and Nivo XRT (60Gy). Participants will receive concurrent thoracic radiation therapy using a standardized 3DCRT or IMRT technique on a linear accelerator operating at 2:6 MV beam energy. The target total dose of thoracic radiation therapy will be 60 Gy in 30 daily fractions of 2 Gy prescribed to the PTV. The participants then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles.
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Induction Chemo-Nivo in Unresectable Stage III NSCLC
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 9 weeksPopulation: he study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
post induction radiographic response by cat scan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, up to 18 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
To assess safety, investigators will evaluate the rate of toxicity as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: date of surgery, approximately 10 weeksPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Rate of converting non-surgical stage III(A-C) to surgically resectable disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post surgery, approximately 10 weeksPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post surgery, approximately 10 weeksPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
MPR rate, defined as number of participants with ≤ 10% residual tumor in lung and lymph nodes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
PFS is defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
defined as the duration of time from start of treatment to time of death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, up to 18 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
patient-reported Quality of Life as measured by FACT-TOI (Functional Assessment of Cancer Therapy - Trial Outcome Index); defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS (lung cancer scale) scores obtained from 7-item questionnaires from the FACT-L (Version 4.0). Questions are on a 5-point scale from 0-4, where 0 = "not at all" and 4 = "very much." Scores range from 0 to 84; higher score indicates better physical aspects of quality of life (QoL).
Outcome measures
Outcome data not reported
Adverse Events
Combination Chemotherapy and Nivolumab and Surgery
Combination Chemotherapy and Nivolumab and Radiation
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