Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT03663166|
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : November 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Radiation: Thoracic Radiotherapy Drug: Platinum Based Chemotherapy Drug: Ipilimumab Drug: Nivolumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable NSCLC|
|Actual Study Start Date :||November 20, 2018|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||March 1, 2027|
Experimental: Radiation and Chemotherapy
Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab.
Radiation: Thoracic Radiotherapy
2 Gy in 30 fractions directed at all sites of suspected disease
Drug: Platinum Based Chemotherapy
Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).
Iplimamab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy
Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression.
Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
- Unacceptable toxicity status at the end of 8-week safety observation period [ Time Frame: At 8 weeks of treatment ]
Unacceptable toxicity defined as:
- Any grade 4 immune related adverse event (irAE)
- Any grade 3 irAE, excluding pneumonitis, that does not downgrade to grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to ≤ grade 1 or baseline within 14 days
- Liver transaminase elevation > 8 × ULN or total bilirubin > 5 × ULN,
- Any ≥ grade 3 non-irAE, with some exclusions.
- 12 month Progression Free Survival (PFS) status [ Time Frame: 12 months post treatment ]PFS is defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration (as defined in Outcome 1) or death due to any cause. Patients last known to be alive without report of progression are censored at date of last disease assessment. For patients with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) will be used as the date of progression.
- 12 month distant metastasis free survival (DMFS) [ Time Frame: 12 months post treatment ]DMFS is defined as the duration from date of registration to date of first documentation of distant metastatic progression beyond the primary tumor site as well as regional lymph nodes assessed by local investigator or symptomatic deterioration (as defined in Outcome 1) or death due to any cause. Patients last known to be alive without report of distant metastatic progression are censored at date of last disease assessment.
- Objective Response Rate (ORR) at 6 months [ Time Frame: 6 months ]ORR is defined as the proportion of all treated subjects whose best overall response is either a complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Best Objective Response (BOR) will also be reported Complete Response (CR) or Partial Response (PR) determinations included in the assessment must be confirmed by a consecutive second (confirmatory) evaluation meeting the criteria for response that is performed at least 4 weeks after the criteria for response are first met. When Stable Disease (SD) is believed to be the best response, it must meet a minimum SD duration of 49 days. Measurements must have met the SD criteria at least once after study entry.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663166
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Austin Lannon 813-745-2169 Austin.Lannon@moffitt.org|
|Principal Investigator: Bradford Perez, MD|
|Sub-Investigator: Scott Antonia, MD, PhD|
|Sub-Investigator: Alberto Chiappori, MD|
|Sub-Investigator: Benjamin Creelan, MD|
|Sub-Investigator: Thomas Dilling, MD|
|Sub-Investigator: Jhanelle Gray, MD|
|Sub-Investigator: Eric Haura, MD|
|Sub-Investigator: Stephen Rosenberg, MD, MS|
|Sub-Investigator: Michael Shafique, MD|
|Sub-Investigator: Tawee Tanvetyanon, MD, MPH|
|United States, North Carolina|
|UNC Limeberger Comprehensive Cancer Center||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Chris Hilliard 919-846-6752 Chris.Hilliard@med.unc.edu|
|Principal Investigator: Ashley Weiner, MD|
|Durham, North Carolina, United States, 27710|
|Contact: Jeffrey Clarke, MD 919-684-8111 firstname.lastname@example.org|
|Contact: John Gibbs (919) 684-1904 email@example.com|
|Principal Investigator:||Bradford Perez, MD||H. Lee Moffitt Cancer Center and Research Institute|