Clinical trial · Interventional
Study of Thalidomide in Treatment of Advanced Nsclc (Dream-003)
Study of Thalidomide With First-line Chemotherapy and as Maintenance Treatment of Advanced Nonsquamous NSCLC With Epidermal Growth Factor Receptor Wild-Type or Unknown Mutation Status: A Multicenter, Randomized, Prospective Clinical Trial
NCT03062800CI-TRIAL-00038941unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Nsclc | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- P+Cisplatin/Carboplatin+T
- description
- Induction therapy (Platinum based chemotherapy combined with antiangiogenic therapy 4-6 cycles): Pemetrexed + Platinum + Thalidomide \[pemetrexed (500mg/m\^2)+cisplatin(75mg/m\^2)or carboplatin(AUC=5) on day 1 of 21-days cycle, ivgtt +thalidomide 100-200mg/d ,oral, qn \] Continue maintenance therapy (It is defined when a drug included in the induction treatment is used as maintenance .Patients who had not progressed during induction phase will be in this phase): Thalidomide 100mg/d ,oral, qn, until either disease progression or unacceptable toxicity.
- interventionNames
- Drug: Thalidomide
- Drug: pemetrexed
- Drug: cisplatin
- Drug: carboplatin
- type
- EXPERIMENTAL
- label
- P+Cisplatin/Carboplatin
- description
- Induction therapy ( Platinum based chemotherapy 4-6 cycles): Pemetrexed + Platinum \[pemetrexed (500mg/m\^2)+cisplatin(75mg/m\^2)or carboplatin(AUC=5) on day 1 of 21-days cycle,ivgtt \] Maintenance therapy (It is defined when a drug included in the induction treatment is used as maintenance .Patients who had not progressed during induction phase will be in this phase): Pemetrexed (500mg/m\^2) on day 1 of 21-days cycle, ivgtt.until either disease progression or unacceptable toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDVilla C, Cagle PT, Johnson M, Patel JD, Yeldandi AV, Raj R, DeCamp MM, Raparia K. Correlation of EGFR mutation status with predominant histologic subtype of adenocarcinoma according to the new lung adenocarcinoma classification of the International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society. Arch Pathol Lab Med. 2014 Oct;138(10):1353-7. doi: 10.5858/arpa.2013-0376-OA. Epub 2014 Feb 26. PMID 24571650
- BACKGROUNDSandler A, Yi J, Dahlberg S, Kolb MM, Wang L, Hambleton J, Schiller J, Johnson DH. Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. J Thorac Oncol. 2010 Sep;5(9):1416-23. doi: 10.1097/JTO.0b013e3181da36f4. PMID 20686429
- BACKGROUNDIwasaki A, Kuwahara M, Yoshinaga Y, Shirakusa T. Basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) levels, as prognostic indicators in NSCLC. Eur J Cardiothorac Surg. 2004 Mar;25(3):443-8. doi: 10.1016/j.ejcts.2003.11.031. PMID 15019676
- BACKGROUNDGridelli C, Maione P, Rossi A. The PARAMOUNT trial: a phase III randomized study of maintenance pemetrexed versus placebo immediately following induction first-line treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. Rev Recent Clin Trials. 2013 Mar;8(1):23-8. doi: 10.2174/15748871112079990040. PMID 23259416
- BACKGROUNDZhou S, Wang F, Hsieh TC, Wu JM, Wu E. Thalidomide-a notorious sedative to a wonder anticancer drug. Curr Med Chem. 2013;20(33):4102-8. doi: 10.2174/09298673113209990198. PMID 23931282
- BACKGROUNDLee SM, James L, Buchler T, Snee M, Ellis P, Hackshaw A. Phase II trial of thalidomide with chemotherapy and as maintenance therapy for patients with poor prognosis small-cell lung cancer. Lung Cancer. 2008 Mar;59(3):364-8. doi: 10.1016/j.lungcan.2007.08.032. Epub 2007 Oct 24.