Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma
Brief Summary: This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.


Options:
A: Arm Label: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Drug: Nivolumab, Drug: Ipilimumab | Arm Label: Placebo + Ipilimumab; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Placebo | Intervention Type: DRUG; Name: Nivolumab; Assigned to Arm(s): Nivolumab + Ipilimumab | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): Nivolumab + Ipilimumab, Placebo + Ipilimumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo + Ipilimumab
B: Arm Label: Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer); Type: EXPERIMENTAL; Interventions: Drug: erlotinib hydrochloride, Drug: cisplatin, Radiation: 3-dimensional conformal radiation therapy, Radiation: intensity-modulated radiation therapy, Procedure: quality-of-life assessment | Arm Label: Arm II (chemotherapy, radiotherapy); Type: ACTIVE_COMPARATOR; Interventions: Drug: cisplatin, Radiation: 3-dimensional conformal radiation therapy, Radiation: intensity-modulated radiation therapy, Procedure: quality-of-life assessment | Intervention Type: DRUG; Name: erlotinib hydrochloride; Assigned to Arm(s): Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer) | Intervention Type: DRUG; Name: cisplatin; Assigned to Arm(s): Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer), Arm II (chemotherapy, radiotherapy) | Intervention Type: RADIATION; Name: 3-dimensional conformal radiation therapy; Assigned to Arm(s): Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer), Arm II (chemotherapy, radiotherapy) | Intervention Type: RADIATION; Name: intensity-modulated radiation therapy; Assigned to Arm(s): Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer), Arm II (chemotherapy, radiotherapy) | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer), Arm II (chemotherapy, radiotherapy)
C: Arm Label: Cisplatinum + conventional RT; Type: ACTIVE_COMPARATOR; Interventions: Drug: cisplatinum, Radiation: Conventional radiotherapy | Arm Label: Cisplatinum + adaptive high dose RT; Type: EXPERIMENTAL; Interventions: Drug: cisplatinum, Radiation: Adaptive radiotherapy | Intervention Type: DRUG; Name: cisplatinum; Assigned to Arm(s): Cisplatinum + adaptive high dose RT, Cisplatinum + conventional RT | Intervention Type: RADIATION; Name: Conventional radiotherapy; Assigned to Arm(s): Cisplatinum + conventional RT | Intervention Type: RADIATION; Name: Adaptive radiotherapy; Assigned to Arm(s): Cisplatinum + adaptive high dose RT
D: Arm Label: Afatinib (BIBW 2992); Type: EXPERIMENTAL; Interventions: Drug: Afatinib | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Afatinib; Assigned to Arm(s): Afatinib (BIBW 2992)

Answer: D