Conditions: Non-Squamous Non-Small Cell Lung Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 34
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (\<) 3 months, and the target sample size is \<100 individuals.

Detailed description:

Arms:
arm 1: Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated at the same day as the start of erlotinib. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream). arm 2: Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated when participants develop rash. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).

Interventions: intervention 1: Erlotinib intervention 2: Metronidazole Actavis intervention 3: Non-active Moisturizing Cream
Intervention descriptions: intervention 1: Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks. intervention 2: Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks. intervention 3: Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).

Protocol document: