Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC

Sun Yat-sen University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Other: Physiological saline; Other: EVOZAC Calming Skin Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT01528488

EVOZAC20110210

Details and patient eligibility

About

The epidermal growth factor receptor (EGFR) has become an important target for cancer therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with the encouraging efficacy in NSCLC is the common side effects, of which the most common one is the specific papular and pustular acne-like rash which affects mainly the face, scalp, and upper torso. But till now, no medicament has been proved effective enough to treat or prevent the EGFR-TKIs associated rash. The EVOZAC® Calming Skin Spray has shown acceptable activity at the rash prevention in our preliminary study, so the investigators conduct the randomized, double-blind, controlled trial to evaluate the efficacy and safety of EVOZAC® Calming Skin Spray in prevention of EGFR-TKIs associated rash in NSCLC.

Full description

Not suitable: no more information is needed to be described.

Enrollment: 118 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven NSCLC diagnosis
• Life expectancy over four weeks
• absolute neutrophil count ≥ 2.0X109/L, Pt ≥ 100X109/L, hemoglobin ≥ 90g/l
• With normal hepatic function(AST, ALT < 2.5 x upper limit of normal , and Total bilirubin ≤ upper limit of normal)
• Suitable for EGFR-TKIs treatment and expectant duration over four weeks
• No specific therapies received within 4 weeks prior to enrollment which may induce similar skin reaction,such as Cetuximab, Sorafenib, Avastin.
• With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTC] grade ≥ 3)
• No other concomitant therapy referred to the face skin during the study
• Signed and dated informed consent

Exclusion criteria

• Performance status ≥ 3(ECOG)
• Pregnant or breast-feeding patients
• The lesion counts can't be evaluated due to concomitant diseases or other conditions
• Not suitable for EGFR-TKIs treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

118 participants in 2 patient groups, including a placebo group

EVOZAC

Experimental group

Description:

EVOZAC should be sprayed to the skin of the total face three times per day.

Treatment:

Other: EVOZAC Calming Skin Spray

Physiological saline

Placebo Comparator group

Description:

Physiological saline should be sprayed to the total face three times per day.

Treatment:

Other: Physiological saline