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

Trial Summary

What is the purpose of this trial?

This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

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.

What data supports the idea that Sutetinib for Non-Small Cell Lung Cancer is an effective drug?

The available research shows that Sutetinib, also known as Sunitinib Malate or Sutent, has some effectiveness in treating Non-Small Cell Lung Cancer (NSCLC). In one study, Sutetinib achieved a 10% response rate in patients whose cancer had progressed after chemotherapy. This means that 10% of the patients saw a reduction in their cancer size. While this response rate is similar to other approved drugs for lung cancer, it indicates that Sutetinib can be a viable option for some patients. Additionally, Sutetinib has shown effectiveness in treating other types of cancer, such as renal cell carcinoma and gastrointestinal stromal tumors, which supports its potential as a cancer treatment. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Sutetinib for non-small cell lung cancer?

Research shows that sunitinib malate, a component of Sutetinib, has shown promising activity in treating advanced non-small cell lung cancer (NSCLC) in patients who have already received other treatments. It works by blocking certain proteins that help cancer cells grow, and has been effective in other cancers like renal cell carcinoma and gastrointestinal stromal tumors. ^{1 2 3 4 5}

What safety data is available for Sutetinib in treating non-small cell lung cancer?

Safety data for Sutetinib, also known as Sunitinib Malate or Sutent, includes findings from a Phase II study on its use in advanced non-small cell lung cancer, where it showed promising activity. Additionally, a Phase I study in healthy Chinese subjects demonstrated that both generic sunitinib and Sutent had comparable safety profiles, supporting their clinical application. These studies suggest that Sutetinib has a well-established safety profile in various conditions, including non-small cell lung cancer. ^{1 5 6 7 8}

Is sunitinib safe for humans?

Sunitinib, also known as Sutent, has been studied for safety in various conditions, including gastrointestinal stromal tumors and renal cell carcinoma. In a study with healthy Chinese subjects, both sunitinib and its original product Sutent showed good safety profiles, suggesting it is generally safe for human use. ^{1 5 6 7 8}

Is the drug Sutetinib Maleate Capsule a promising treatment for Non-Small Cell Lung Cancer?

Yes, Sutetinib Maleate Capsule, also known as Sunitinib Malate or Sutent, shows promise as a treatment for Non-Small Cell Lung Cancer. It has demonstrated positive effects when used alone in patients with advanced stages of this cancer. ^{1 5 8 9 10}

How is the drug Sutetinib different from other treatments for non-small cell lung cancer?

Sutetinib (Sunitinib Malate) is unique because it is a multi-targeted therapy that inhibits several receptor tyrosine kinases, which are proteins involved in the growth of cancer cells. It is administered on a specific schedule of 4 weeks on treatment followed by 2 weeks off, which is different from many other cancer treatments. ^{1 5 8 9 10}

Eligibility Criteria

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

I am 18 years old or older.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 (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 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 (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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. [2021]

2. Ireland 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. [2022]

4. England 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Sunitinib inhibits MEK/ERK and SAPK/JNK pathways and increases sodium/iodide symporter expression in papillary thyroid cancer. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and bioequivalence of sunitinib and Sutent® in Chinese healthy subjects: an open-label, randomized, crossover study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The potential of sunitinib as a therapy in ovarian cancer. [2018]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Sunitinib malate synergistically potentiates anti-tumor effect of gemcitabine in human bladder cancer cells. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting VEGF-VEGFR Pathway by Sunitinib in Peripheral Primitive Neuroectodermal Tumor, Paraganglioma and Epithelioid Hemangioendothelioma: Three Case Reports. [2022]