Overview

Study of Thalidomide in Treatment of Advanced Nsclc (Dream-003)

Status:
Unknown status

Trial end date:
2021-11-01

Target enrollment:
0

Participant gender:
All

Summary

The study for innovative strategies is warranted in the treatment of advanced non-squamous NSCLC with epidermal growth factor receptor wild-type or unknown mutation status because the outcomes remain unsatisfactory for most patients. Maintenance treatment after first-line chemotherapy is a very interesting strategy that has been largely investigated in the last years. This study is to evaluate the efficacy and toxicity of thalidomide in combination with chemotherapy and as maintenance treatment in patients with advanced non-squamous NSCLC.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Qilu Hospital of Shandong University

Treatments:

Carboplatin
Cisplatin
Pemetrexed
Thalidomide

Criteria

Inclusion Criteria:

1. stage Ⅳ non-squamous NSCLC with epidermal growth factor receptor wild-type or unknown
mutation status confirmed by molecular biology and histology.

2. age 18-70 years.

3. Eastern Cooperative Oncology Group performance status of 0 or 1 and life expectancy
greater than 3 months.

4. no previous treatment with chemotherapy or radiotherapy

5. adequate bone marrow, hepatic, and renal function

6. measurable or evaluable disease

7. informed consent

8. negative pregnancy test and adequate contraception for the duration of treatment

Exclusion Criteria:

1. malignancy during the 5 years previous to the diagnosis of NSCLC (unless nonmelanoma
skin cancer or early cervical cancer)

2. surgery within 4 weeks

3. history of major hemoptysis

4. recent history of bleeding or thrombotic events

5. brain metastasis

6. uncontrolled hypertension

7. ongoing therapeutic anticoagulation