Non-Small Cell Lung Cancer
Conditions
Brief summary
This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.
Interventions
DRUGNivolumab
Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles)
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have a performance status of 0-1 (ECOG Performance Scale) * Patient must be a candidate for concurrent chemoradiation * Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor board assessment * PD-L1 tumor expression greater than or equal to 1% * Presence of measurable disease according to RECIST v1.1 * Adequate organ function * Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor cellularity)
Exclusion criteria
* Active autoimmune disease that has requires immunosuppressive therapy in the previous year * Uncontrolled primary or acquired immunodeficiency (including HIV) * Baseline corticosteroid usage (\>10 mg prednisone or equivalent daily) aside from supportive medication use * Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions * Presence of significant comorbidities precluding participation in a clinical study as determined by investigator * Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment * Has a known history of active TB (Bacillus Tuberculosis) * Has known active Hepatitis B or Hepatitis C * Has received a live vaccine within 30 days of enrollment * Known diagnosis of Interstitial Lung Disease * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Approximately two years after enrollment | Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first. |
| Treatment Tolerance | Approximately three years after enrollment | Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Approximately two years after enrollment | Frequency of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria 5.0 classified by body system, grade, and attribution. |
| Best overall response rate (BOR) | Approximately two years after enrollment | Defined as the proportion of participants who achieve a confirmed either a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by central review. |
| Overall survival | Approximately two years after enrollment | Defined as the time from start of treatment to the date of death from any cause.. |
Countries
United States
Contacts
CONTACTNithya Ramnath, MD
CONTACTGarth W Strohbehn, MD MSc
PRINCIPAL_INVESTIGATORNithya Ramnath, MD
VA Ann Arbor Healthcare System, Ann Arbor, MI
Outcome results
None listed