Eligibility Details:
Inclusion Criteria:
- Histologically diagnosed NSCLC
- Age 18 or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Patients must be able to provide informed consent
- Patients must meet the criteria above AND fulfill the criteria below for entry into
one of the 3 cohorts
Cohort 1
1. Stage III NSCLC as per the American Joint Committee on Cancer 8th edition (AJCC 8th
ed.)
2. Appropriate to undergo concurrent chemotherapy and radiation
3. Planned radiation dose must be between 54 and 66 Gy
4. Chemotherapy regimen must include a platinum agent plus one of the following doublet
agents: etoposide, pemetrexed, paclitaxel, vinorelbine, docetaxel, gemcitabine or
vincristine
5. Day 1 platinum dose must be ≥ carboplatin 1.6 AUC or cisplatin 30 mg/m2
6. No prior system chemotherapy (induction) for their stage III NSCLC, any adjuvant
chemotherapy given for resected disease must have been at least 100 days prior to
enrollment
Cohort 2
1. Stage IV NSCLC or stage III NSCLC, as per the AJCC 8th ed.
2. Planning to start systemic cytotoxic chemotherapy, without concurrent radiation
3. Previous treatment with tyrosine kinase inhibitors or immunotherapy (PD-1, PD-L1,
CTLA4 directed antibodies) is allowed as long as no cytotoxic chemotherapy was given
concurrently
4. Previous palliative radiation is permitted, but must have been completed at least at
least 21 days prior to the initiation of treatment
5. Chemotherapy regimen must include a platinum agent plus one of the following doublet
agents: etoposide, pemetrexed, paclitaxel, vinorelbine, docetaxel, gemcitabine or
vincristine
6. Day 1 platinum dose must be ≥ carboplatin 1.6 AUC or cisplatin 30 mg/m2
7. If cytotoxic chemotherapy was previously given for adjuvant or stage III NSCLC it must
have been at least 100 days prior to enrollment
Cohort 3
1. Patients with advanced NSCLC set to undergo palliative radiation to the primary or
regional or distant metastatic lesion(s), including intracranial lesions
2. Radiation dose scheduling must be 2.5 to 4.0 Gy on days 1 through 3 for extracranial
treatment, ideally 40 Gy in 15 fractions, 20 Gy in 5 fractions, or 30 Gy in 10
fractions.
3. Radiation dose for brain lesions must be 6 to 9 Gy per dose, ideally 30 to 35 Gy in 5
daily fractions or 27 Gy in 3 fractions on alternating days
4. No plans for concurrent chemotherapy to be given
5. Five patients in cohort 3 will receive radiation to the primary tumor and five
patients will receive radiation to brain lesions
Exclusion Criteria:
- Any other malignancy in the last five years other than adequately treated non-melanoma
skin cancer
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
