Purpose of this Study
We are doing this study to find out if adding a procedure called stereotactic body radiation therapy (SBRT) to the standard treatment for advanced NSCLC can improve outcomes for patients with this type of cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with stage IV NSCLC
- Have a non-squamous form of cancer
- Have not been previously treated with systemic chemotherapy or immunotherapy
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
- Are diagnosed with stage IV NSCLC
- Have a non-squamous form of cancer
- Have not been previously treated with systemic chemotherapy or immunotherapy
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:
- If you are in Group 1, you will receive the standard therapy for the type of cancer you have
- If you are in Group 2, you will receive the standard therapy for the type of cancer you have and also receive SBRT
The standard therapy for advanced NSCLC involves the use of different immunotherapy drugs, which may or may not be combined with chemotherapy. There are several drug combinations to choose from, and the study doctor will decide which standard treatment option is best for you.
The standard therapy options you might receive in this study are:
- Nivolumab + ipilimumab (immunotherapy without chemotherapy) for up to 2 years
- Pembrolizumab and carboplatin + pemetrexed (immunotherapy and chemotherapy) for up to 2 years
- Nivolumab + ipilimumab and carboplatin + pemetrexed (immunotherapy and chemotherapy) for up to 2 years
- Pembrolizumab and carboplatin + paclitaxel (immunotherapy and chemotherapy) for up to 2 years
- Pembrolizumab and carboplatin + nab-paclitaxel (immunotherapy and chemotherapy) for up to 2 years
- Nivolumab + ipilimumab and carboplatin + paclitaxel (immunotherapy and chemotherapy) for up to 2 years
If you are assigned to Group 2 and receive SBRT along with standard therapy, you will not get SBRT on the same days you take an immunotherapy or chemotherapy drug.
- If you are in Group 1, you will receive the standard therapy for the type of cancer you have
- If you are in Group 2, you will receive the standard therapy for the type of cancer you have and also receive SBRT
The standard therapy for advanced NSCLC involves the use of different immunotherapy drugs, which may or may not be combined with chemotherapy. There are several drug combinations to choose from, and the study doctor will decide which standard treatment option is best for you.
The standard therapy options you might receive in this study are:
- Nivolumab + ipilimumab (immunotherapy without chemotherapy) for up to 2 years
- Pembrolizumab and carboplatin + pemetrexed (immunotherapy and chemotherapy) for up to 2 years
- Nivolumab + ipilimumab and carboplatin + pemetrexed (immunotherapy and chemotherapy) for up to 2 years
- Pembrolizumab and carboplatin + paclitaxel (immunotherapy and chemotherapy) for up to 2 years
- Pembrolizumab and carboplatin + nab-paclitaxel (immunotherapy and chemotherapy) for up to 2 years
- Nivolumab + ipilimumab and carboplatin + paclitaxel (immunotherapy and chemotherapy) for up to 2 years
If you are assigned to Group 2 and receive SBRT along with standard therapy, you will not get SBRT on the same days you take an immunotherapy or chemotherapy drug.
Study Details
Full Title
A082002: A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy with or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer
Principal Investigator
Thomas
Stinchcombe
Protocol Number
PRO00110932
NCT ID
NCT04929041
Phase
II/III
Enrollment Status
OPEN TO ACCRUAL