Table S1.
Study design, endpoints, and study assessment
| Study type | Multicenter, randomized, controlled, open-label, prospective, and nationwide Phase II trial |
| Involved patients with unresectable or locally advanced NSCLC | |
| Randomization was centralized, and patients were stratified according to ECOG-PS (0–1 versus 2) and stage of disease (I–II versus III) | |
| Criteria for inclusion | Aged over 18 years |
| Histologically confirmed stage IA–IIIB unresectable NSCLC | |
| ECOG-PS 0–2 | |
| Adequate hematologic, hepatic, renal, and respiratory function | |
| No previous CT or RT treatment | |
| Main exclusion criteria | Previous CT or RT treatment |
| Previous treatment with erlotinib or any anti-EGFR | |
| Any concomitant severe disorder or neoplasia | |
| Pregnancy | |
| Primary endpoint | Feasibility and tolerability pattern of the addition of erlotinib to thoracic RT |
| Secondary endpoint | Efficacy of the combined treatment: |
| – Progression-free survival (PFS) | |
| – Time to progression (TTP) | |
| – Time to treatment failure (TTF) | |
| – Overall survival | |
| – Cancer specific survival (CSS) | |
| – Objective response rate (ORR) | |
| Study arms | – Control arm (CA): patients receiving 66 Gy with three-dimensional conformal thoracic RT (5 days/week, conventional fractionation 200 cGy/day) |
| – Experimental arm (EA): patients receiving the same radiotherapy dose scheme but combined with erlotinib (150, 100, or 50 mg po for maximum 6 months) | |
| Number of patients | On the basis of primary endpoint and the lack of information concerning the combination of erlotinib and |
| radiotherapy, the total number of patients enrolled in the study was 90, ie, 30 in the CA and 60 in the EA | |
| Ethics and consent | All patients gave their informed consent before participating in the study. Procedures were performed in accordance with the guidelines established by the ethics committee of each participating center and the Declaration of Helsinki |
Abbreviations: NSCLC, non-small-cell lung cancer; ECOG-PS, Eastern Cooperative Oncology Group Performance Status; EGFR, epidermal growth factor receptor; RT, radiotherapy; CT, chemotherapy; po, per oral administration.