Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03786692
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2018-12-21
Brief Title:
Phase II Randomized Trial of CarboplatinPemetrexedBevacizumab- Atezolizumab in Stage IV NSCLC
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
TH-138 Phase II Randomized Trial of Carboplatin Pemetrexed Bevacizumab With or Without Atezolizumab in Stage IV Non-squamous NSCLC Patients Who Harbor a Sensitizing EGFR Mutation or Have Never Smoked
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
While cigarette smoking remains the primary cause of most lung cancer cases lung carcinoma in never smokers account for nearly 20 percent of cases Never smokers with lung cancer typically present with different molecular profiles from that of smokers which results in prognostic and therapeutic implications Molecular changes in NSCLC that have therapeutic significance include mutations in the epidermal growth factor receptor EGFR and rearrangements in the anaplastic lymphoma kinase ALK gene These driver mutations typically are present in lung tumors found in never or light smokers
The addition of bevacizumab to carboplatin and paclitaxel in first-line treatment of non-squamous NSCLC showed improved survival compared to carboplatin and paclitaxel alone 123 vs 103 months respectively Results from the POINTBREAK trial demonstrated that carboplatin pemetrexed bevacizumab is an alternative option to carboplatin paclitaxel bevacizumab with comparable survival but less toxicity In recent years immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients The PD-1 inhibitor nivolumab and the PD-L1 inhibitor atezolizumab have shown prolonged survival in comparison to docetaxel in patients who previously progressed with chemotherapy irrespective of PD-L1 expression Thus this study combines immunotherapeutic agent atezolozumab with an ant-angiogenic agent bevacizumab and double platinum therapy carboplatin and pemetrexed
The addition of bevacizumab to carboplatin and paclitaxel in first-line treatment of non-squamous NSCLC showed improved survival compared to carboplatin and paclitaxel alone 123 vs 103 months respectively Results from the POINTBREAK trial demonstrated that carboplatin pemetrexed bevacizumab is an alternative option to carboplatin paclitaxel bevacizumab with comparable survival but less toxicity In recent years immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients The PD-1 inhibitor nivolumab and the PD-L1 inhibitor atezolizumab have shown prolonged survival in comparison to docetaxel in patients who previously progressed with chemotherapy irrespective of PD-L1 expression Thus this study combines immunotherapeutic agent atezolozumab with an ant-angiogenic agent bevacizumab and double platinum therapy carboplatin and pemetrexed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-1077 | OTHER | Fox Chase Cancer Center | None |