Sutetinib for Non-Small Cell Lung Cancer

Recruiting at 25 trial locations

Overseen By Dawei Zhang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Teligene US

Must not be taking: EGFR-TKI, CYP3A4 inhibitors

Disqualifiers: CNS metastases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Sutetinib (Sutetinib Maleate Capsule) to evaluate its safety and effectiveness for individuals with Non-Small Cell Lung Cancer (NSCLC). It targets patients whose cancer has specific uncommon mutations in the EGFR gene, which influences cell growth. The study includes those whose cancer has advanced locally or metastasized and who have undergone one or fewer rounds of chemotherapy. Ideal candidates have these specific mutations and a measurable tumor. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you must stop all current medications. However, you cannot use drugs or foods that affect CYP3A4 within 14 days before joining. Also, you can't have had certain cancer treatments or surgeries recently. It's best to discuss your specific medications with the trial team.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic anti-tumor therapy, including chemotherapy, immunotherapy, and radiation therapy, at least 4 weeks before joining. You also need to avoid drugs or foods that affect a specific liver enzyme (CYP3A4) for at least 14 days before starting the trial.

Is there any evidence suggesting that Sutetinib Maleate Capsule is likely to be safe for humans?

Studies have shown that Sutetinib, a treatment tested for non-small cell lung cancer, is generally well-tolerated. In a study with 47 participants with advanced cancer, the treatment had a low response rate, but about 23.4% of patients experienced stable disease, meaning their cancer did not worsen. Importantly, the treatment maintained a good safety profile.

Previous research indicates that Sutetinib was used in patients who had already received many other treatments, yielding promising results. The treatment remained safe and did not cause severe side effects. This suggests that while not everyone benefits from the treatment, it is generally safe for recipients.

These findings provide insight into the safety of Sutetinib for treating certain types of lung cancer, especially those with uncommon EGFR mutations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for NSCLC?

Sutetinib is unique because it targets non-small cell lung cancer through a novel mechanism of action. Unlike traditional treatments like chemotherapy and immunotherapy, which often have significant side effects and variable effectiveness, Sutetinib is designed to specifically inhibit pathways crucial for cancer cell survival and proliferation. This targeted approach has the potential to offer more effective treatment with fewer side effects, making researchers excited about its promise in improving patient outcomes.

What evidence suggests that Sutetinib might be an effective treatment for non-small cell lung cancer?

Research has shown that Sutetinib Maleate, which participants in this trial will receive, might effectively treat non-small cell lung cancer (NSCLC). In earlier studies, patients who took Sutetinib experienced stable cancer for about 11.9 weeks on average, meaning it did not worsen during that period. On average, patients lived for about 37.1 weeks after starting treatment. Additionally, 17% of patients had stable disease, indicating their cancer did not grow or shrink significantly. These results suggest that Sutetinib Maleate could be a promising option for individuals with certain rare EGFR mutations in NSCLC. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with a specific type of advanced lung cancer (NSCLC) that has certain uncommon EGFR mutations. They should have good organ function, an ECOG score of 0-2, and at least one measurable lesion. Participants must not have had extensive prior treatments or serious health issues like active brain metastases or heart disease.

Inclusion Criteria

My blood, liver, kidney, and clotting tests are within normal ranges.

My tumor has a specific rare EGFR mutation but no other sensitive mutations.

Willingness of all subjects of childbearing potential to use acceptable methods of birth control

Exclusion Criteria

You have a known problem with alcohol or drugs.

I am not pregnant or breastfeeding.

I cannot swallow pills or have a chronic stomach problem affecting food absorption.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sutetinib Maleate capsules as monotherapy for the treatment of locally advanced or metastatic NSCLC

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sutetinib Maleate Capsule

Trial Overview The trial is testing Sutetinib Maleate Capsule's safety and effectiveness in treating NSCLC with specific EGFR mutations. It's an open-label Phase 2b study, meaning both researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: Sutetinib Maleate Arm Experimental Treatment 1 Intervention

Sutetinib capsules monotherapy

Sutetinib Maleate Capsule is already approved in United States, European Union for the following indications:

Approved in United States as Sutent for:

• Gastrointestinal Stromal Tumor (GIST)
• Renal Cell Carcinoma (RCC)
• Pancreatic Neuroendocrine Tumors (pNET)

Approved in European Union as Sutent for:

• Gastrointestinal Stromal Tumors (GIST)
• Renal Cell Carcinoma (RCC)
• Pancreatic Neuroendocrine Tumors (pNET)

Who Is Running the Clinical Trial?

Teligene US

Lead Sponsor

Trials

3

Recruited

230+

Published Research Related to This Trial

Sunitinib effectively inhibits the growth and migration of papillary thyroid cancer cells with the RET/PTC1 rearrangement, demonstrating a dose-dependent effect with a mean lethal concentration of 1.81 microM.

The drug works by blocking specific signaling pathways (MEK/ERK and SAPK/JNK), leading to cell cycle arrest and increased expression of the sodium/iodide symporter (NIS), which is important for iodide metabolism in thyroid cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sunitinib inhibits MEK/ERK and SAPK/JNK pathways and increases sodium/iodide symporter expression in papillary thyroid cancer. Fenton, MS., Marion, KM., Salem, AK., et al.[2018]

Sunitinib malate, a multitargeted tyrosine kinase inhibitor, showed an objective response rate of 11.1% in 63 patients with previously treated advanced non-small-cell lung cancer (NSCLC), indicating some effectiveness as a treatment option.

The treatment was generally well tolerated, with a median progression-free survival of 12 weeks and median overall survival of 23.4 weeks, suggesting that sunitinib has a favorable safety profile and potential for further investigation in combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. Socinski, MA., Novello, S., Brahmer, JR., et al.[2022]

Sunitinib malate demonstrated a strong anti-tumor effect against human bladder cancer cell lines, showing a dose- and time-dependent response similar to conventional drugs like cisplatin and gemcitabine.

The study found that sunitinib can synergistically enhance the effectiveness of gemcitabine, indicating a potential for combined therapy in treating bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sunitinib malate synergistically potentiates anti-tumor effect of gemcitabine in human bladder cancer cells. Yoon, CY., Lee, JS., Kim, BS., et al.[2021]

A phase-I clinical trial involving 48 healthy Chinese subjects demonstrated that the generic version of sunitinib is bioequivalent to the original Sutent®, with pharmacokinetic parameters falling within the acceptable range for bioequivalence.

Both sunitinib and Sutent® exhibited comparable safety profiles, supporting the use of generic sunitinib as a viable alternative treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and bioequivalence of sunitinib and Sutent® in Chinese healthy subjects: an open-label, randomized, crossover study. Wang, Y., Deng, Q., Gao, Z., et al.[2023]

Sunitinib malate (Sutent) was approved by the FDA for treating gastrointestinal stromal tumors (GIST) after patients showed disease progression or intolerance to imatinib, demonstrating a median time-to-tumor progression of 27.3 weeks compared to 6.4 weeks for placebo.

In advanced renal cell carcinoma, sunitinib showed partial response rates of 25.5% and 36.5% in two studies, with median response durations of 27.1 and 54 weeks, although it was associated with common side effects like diarrhea and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. Goodman, VL., Rock, EP., Dagher, R., et al.[2022]

In a phase II study involving 75 patients with non-small cell lung cancer (NSCLC), maintenance treatment with vandetanib after chemotherapy showed a progression-free survival (PFS) rate of 44.4% at 3 months, which supports its efficacy compared to a placebo.

Vandetanib was generally well tolerated, with common side effects including rash (77.3%) and diarrhea (60.0%), indicating a manageable safety profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, phase II study of vandetanib maintenance for advanced or metastatic non-small-cell lung cancer following first-line platinum-doublet chemotherapy. Ahn, JS., Lee, KH., Sun, JM., et al.[2022]

Sunitinib (Sutent) is an effective treatment for metastatic renal cell carcinoma (RCC), showing a 37% response rate and 48% stable disease, making it the preferred first-line therapy for this cancer.

Sunitinib also demonstrates efficacy in gastrointestinal stromal tumors (GIST) with an 8% response rate and 70% stable disease, contributing to a median survival of 20 months, and shows moderate activity in breast cancer and non-small cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma and various other solid tumors. Polyzos, A.[2018]

Sunitinib malate is a small molecule kinase inhibitor effective against various tyrosine kinase receptors and has recently been approved for treating advanced pancreatic neuroendocrine tumors, in addition to its existing approvals for renal cell carcinoma and gastrointestinal stromal tumors.

The use of sunitinib in treating rare tumors like peripheral primitive neuroectodermal tumor (pPNET), paraganglioma (PGL), and epithelioid hemangioendothelioma (EHE) is promising due to these tumors' overexpression of pro-angiogenic factors, suggesting that sunitinib may help manage these difficult-to-treat conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting VEGF-VEGFR Pathway by Sunitinib in Peripheral Primitive Neuroectodermal Tumor, Paraganglioma and Epithelioid Hemangioendothelioma: Three Case Reports. Prochilo, T., Savelli, G., Bertocchi, P., et al.[2022]

Sunitinib malate is a multi-kinase inhibitor approved for treating advanced renal cell carcinoma and other specific tumors, showing modest antitumor activity in ovarian cancer based on Phase I and II trials.

The drug has an acceptable safety profile, but further research is needed to better understand its toxicity and to explore combination therapies for enhanced efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of sunitinib as a therapy in ovarian cancer. Leone Roberti Maggiore, U., Valenzano Menada, M., Venturini, PL., et al.[2018]

In a phase II study involving 47 patients with advanced non-small cell lung cancer (NSCLC), sunitinib showed a low objective response rate of 2.1%, but 23.4% of patients experienced stable disease for at least 8 weeks, indicating some potential for disease control.

The treatment was generally well tolerated, with a median progression-free survival of 11.9 weeks and a median overall survival of 37.1 weeks, suggesting that sunitinib may be a viable option for patients who have not responded to platinum-based chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. Novello, S., Scagliotti, GV., Rosell, R., et al.[2021]

Citations

1. pfizer.com pfizer.com/news/press-release/press-release-detail/new_data_evaluating_sutent_cp_751_871_and_axitinib_in_patients_with_non_small_cell_lung_cancer

New Data Evaluating SUTENT, CP-751871 and Axitinib in ... The objective response rate was 2.1 percent. 17 percent of patients had stable disease, and observed median overall survival was 37.1 weeks. The ...

2. withpower.com withpower.com/trial/phase-2-carcinoma-non-small-cell-lung-8-2023-7a83b

Sutetinib for Non-Small Cell Lung Cancer The treatment was generally well tolerated, with a median progression-free survival of 11.9 weeks and a median overall survival of 37.1 weeks, suggesting that ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00953459

Sunitinib Malate in Treating Patients With Small Cell Lung ... Study Overview​​ RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23761052/

Sunitinib malate in previously untreated, nonsquamous ... This study explored the safety/efficacy of S in elderly patients with previously untreated NSCLC. Primary objective: disease control rate (DCR) at six-weeks.

5. cancernetwork.com cancernetwork.com/view/data-show-antitumor-activity-sunitinib-patients-nonsmall-cell-lung-cancer-and-irradiated-brain

Data Show Antitumor Activity With Sunitinib in Patients ... Interim results from an open-label, phase II trial evaluating sunitinib malate (Sutent) showed progression free survival of 9.9 weeks in non– ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21610524/

Phase II study of sunitinib in patients with non-small cell ... Median progression-free survival was 9.4 weeks (90% confidence interval [CI]: 7.5-13.1), and median overall survival was 25.1 weeks (95% CI: 13.4-35.5). The ...

7. withpower.com withpower.com/trial/phase-2-carcinoma-non-small-cell-lung-2-2022-c125a

Sutetinib for Non-Small Cell Lung Cancer In a phase II study involving 47 patients with advanced non-small cell lung cancer (NSCLC), sunitinib showed a low objective response rate of 2.1%, but 23.4% of ...

8. ar.iiarjournals.org ar.iiarjournals.org/content/30/12/5169

Response and Safety of Sunitinib in a Heavily Pre-treated ... Conclusion: In this case, sunitinib shows promising single-agent activity in pretreated non-small cell lung cancer, with a good toxicity profile and flexible ...