CIrculating Tumour DNA in Lung Cancer (CITaDeL): Optimizing Sensitivity and Clinical Utility

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