36 Participants Needed

Cabozantinib + Pembrolizumab for Lung Cancer

(LUNG-IST-127 Trial)

Recruiting at 1 trial location
LF
AG
Ryan Nguyen profile photo
Overseen ByRyan Nguyen
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Illinois at Chicago
Must be taking: Pembrolizumab, Carboplatin, Paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new maintenance treatment for individuals with metastatic squamous non-small cell lung cancer. Researchers aim to evaluate the effectiveness of combining two drugs, cabozantinib (a cancer medication) and pembrolizumab (an immunotherapy drug), in controlling the disease after initial treatment. Individuals with this specific type of lung cancer who have responded well to their first round of therapy might be suitable candidates. The study also examines the treatment's safety and its impact on patients' quality of life. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received certain cancer treatments or radiation therapy shortly before starting the trial, and some medications like specific anticoagulants are not allowed. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of cabozantinib and pembrolizumab is generally well-tolerated. In earlier studies, patients with various types of cancer, including lung cancer, received these treatments and often improved without severe side effects.

Some patients experienced side effects, which are common with cancer treatments. These included fatigue, diarrhea, and high blood pressure. However, most side effects were manageable with medical care.

This study is in phase II, indicating that earlier research has already demonstrated some safety. This phase helps researchers learn more about the safety and effectiveness of the combination for patients with specific cancers, like lung cancer.

Overall, evidence suggests that while some side effects may occur, the combination is considered safe enough to continue testing in clinical trials.12345

Why are researchers excited about this study treatment for lung cancer?

Researchers are excited about cabozantinib and pembrolizumab for lung cancer because these drugs work together in a unique way. Cabozantinib targets multiple pathways that help tumors grow and spread, offering a broader attack on cancer cells compared to standard treatments like chemotherapy. Pembrolizumab, on the other hand, is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. This combination aims to not only halt cancer growth but also harness the body's own defenses to fight the disease, potentially leading to better outcomes for patients.

What evidence suggests that cabozantinib and pembrolizumab might be an effective treatment for lung cancer?

Research has shown that using cabozantinib and pembrolizumab together may help treat metastatic squamous non-small cell lung cancer (sqNSCLC). In one study, 65.8% of patients experienced tumor shrinkage, indicating a positive response to the treatment. On average, patients lived for about 10.45 months without their cancer worsening. This combination is already approved for certain lung cancers and has successfully reduced tumor size and improved patient health. In this trial, all participants will receive cabozantinib and pembrolizumab as maintenance therapy following induction therapy. These findings suggest that cabozantinib and pembrolizumab could serve as an effective ongoing treatment option for patients.12678

Are You a Good Fit for This Trial?

Adults with metastatic squamous Non-Small Cell Lung Cancer who've had prior treatment without disease progression. They must be in good health otherwise, understand the study and consent to it, use contraception, and have no other active cancers or severe allergies to trial drugs.

Inclusion Criteria

My recent tests show my organs are functioning well.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
See 10 more

Exclusion Criteria

I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.
I haven't taken any kinase inhibitor medication in the last 2 weeks.
I haven't had any cancer treatment in the last 4 weeks.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants receive 4 cycles of induction therapy with pembrolizumab, carboplatin, and nab-paclitaxel or paclitaxel

12 weeks

Maintenance Therapy

Participants receive maintenance therapy with cabozantinib and pembrolizumab following disease control

19 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cabozantinib
  • Pembrolizumab
Trial Overview The effectiveness of Cabozantinib combined with Pembrolizumab as a maintenance therapy for lung cancer patients post-induction therapy is being tested. The goal is to see how well these drugs work together after initial chemotherapy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: SingleExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, an immune checkpoint inhibitor, can cause pneumonitis in 1%-5% of patients, and this case report highlights an atypical presentation of this side effect in a patient with metastatic squamous cell carcinoma.
The patient was successfully treated with steroid therapy after ruling out other potential causes, leading to complete resolution of the pneumonitis, emphasizing the importance of recognizing and managing atypical cases of checkpoint inhibitor-pneumonitis.
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis.Jeon, WJ., Nguyen, J., Castillo, DR., et al.[2023]
Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.
In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]

Citations

LUNG-IST-127: A pilot phase II study of maintenance ...LUNG-IST 127 is a pilot phase II, single-arm clinical trial of maintenance cabozantinib in combination with pembrolizumab for patients with metastatic sqNSCLC
Analysis of the Efficacy and Safety of Cabozantinib ...In several landmark trials, Atezolizumab improved key clinical outcomes. In metastatic NSCLC, it significantly prolonged overall survival (OS) ...
Pembrolizumab/Cabozantinib Shows Encouraging ...Pembrolizumab plus cabozantinib showed promising activity with an objective response rate of 65.8%, median progression-free survival of 10.45 months, and ...
Cabozantinib + Pembrolizumab for Lung CancerIt is approved for use in certain types of lung cancer and has been effective in reducing tumor size and improving patient outcomes. Show more ...
Pembrolizumab/Cabozantinib Combo Shows Promising ...Data reported with pembrolizumab (Keytruda) plus cabozantinib (Cabometyx) demonstrated that the combination regimen is both highly active ...
Pembrolizumab/Cabozantinib Combo Provides Benefit in ...Additional results indicated that the median progression-free survival was 10.4 months (95% CI, 6.3-not reached [NR]), and the median time to ...
Pembrolizumab and cabozantinib in recurrent metastatic head ...Pembrolizumab and cabozantinib in recurrent metastatic head and neck squamous cell carcinoma: a phase 2 trial
ASCO 2022: New Cabometyx® data show encouraging ...These data show that the therapeutic potential of Cabometyx as a key treatment option in a broad range of tumors is continuing to be realized.
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