ATATcH Alternating Treatment Plans for Advanced Cancer

Required: PD-L1 (CD274) any tested (testing recommended; any PD-L1 expression Tumor Proportion Score (TPS) status eligible)

Patients may have ANY PD-L1 expression Tumor Proportion Score (TPS) status. Tissue testing for PD-L1 is strongly recommended. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patient may still be eligible.

Required: PD-L1 (CD274) any tested (testing recommended; any PD-L1 expression CPS status eligible)

Patients may have ANY PD-L1 expression Tumor Proportion Score (CPS) status. Tissue testing for PD-L1 IHC on samples demonstrating recurrent/metastatic disease is strongly recommended, though testing may be performed on initial diagnostic specimens. If PD-L1 expression CPS is unevaluable or the testing could not be completed, the patient will still be considered eligible.

Excluded: EGFR mutation (except exon 20 insertion)

Patients with known EGFR mutations (except exon 20 insertion)...are excluded.

Excluded: BRAF V600

Patients with known...BRAF mutations (V600)...are excluded.

Excluded: MET exon 14 skipping

Patients with known...MET Exon14 skipping...are excluded.

Excluded: ALK fusion

Patients with known...ALK...translocations...are excluded.

Excluded: ROS1 fusion

Patients with known...ROS1 translocations...are excluded.

Allowed: CDKN2A p16 expression (oropharynx only, highly desirable, not required)

Tumor expression of p16 by immunohistochemistry is highly desirable for patients with Oropharyngeal primaries. Positive p16 expression is defined as strong and diffuse nuclear and cytoplasmic staining in 70% or more of the tumor cells. If HPV status was previously tested using this method, no additional testing is required. If results are not available or are not possible patient will still be considered eligible.

Cannot have received: systemic chemotherapy or immunotherapy

Exception: Chemotherapy and immunotherapy for non-metastatic disease (e.g. adjuvant therapy) or immunotherapy for locally advanced Stage III disease is allowed if at least 6 months have elapsed between the last dose of the prior therapy and study registration.

Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible.

Cannot have received: checkpoint inhibitor

Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible.

Cannot have received: systemic chemotherapy or immunotherapy

Exception: Patients who have received prior chemotherapy or cetuximab with radiation for curative intent treatment of locally advanced head and neck cancer whose disease has progressed after at least 6 months will be eligible.

Prior systemic chemotherapy or immunotherapy for recurrent/metastatic head and neck squamous cell carcinoma. Patients treated with any prior checkpoint inhibitors for recurrent/metastatic head and neck cancer are ineligible.

Cannot have received: checkpoint inhibitor

Patients treated with any prior checkpoint inhibitors for recurrent/metastatic head and neck cancer are ineligible.