Sigvotatug Vedotin vs Docetaxel for Lung Cancer

Recruiting at 426 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Seagen Inc.

Must be taking: Platinum-based chemotherapy, Anti-PD-(L)1

Must not be taking: Antimicrotubule agents

Disqualifiers: Life expectancy < 3 months, Respiratory conditions, Peripheral neuropathy, Uncontrolled diabetes, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 5 years

670 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, sigvotatug vedotin, against a standard drug, docetaxel, in patients with advanced lung cancer. The goal is to see if the new drug works better and to understand its side effects. Docetaxel (Taxotere) is a well-established chemotherapy agent used in the treatment of advanced non-small cell lung cancer (NSCLC), often after failure of first-line treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had any systemic anticancer therapy within 21 days before starting the trial.

What data supports the effectiveness of the drug Docetaxel for lung cancer?

Docetaxel has been shown to improve survival and quality of life in patients with advanced non-small-cell lung cancer (NSCLC), especially as a second-line treatment after other therapies have failed. Clinical trials have demonstrated that patients treated with Docetaxel had longer survival times and better quality of life compared to those receiving other treatments or supportive care. ^{1 2 3 4 5}

Is Sigvotatug Vedotin vs Docetaxel safe for lung cancer treatment?

Docetaxel, also known as Taxotere, has been widely studied and is generally considered safe for treating lung cancer, though it can cause side effects like neutropenia (low white blood cell count) and peripheral neuropathy (nerve damage). It has been shown to improve quality of life for many patients without significant negative impacts. There is no specific safety data available for Sigvotatug Vedotin in the provided research. ^{1 2 3 6 7}

What makes Sigvotatug Vedotin unique compared to other lung cancer drugs?

Sigvotatug Vedotin (SGN-B6A) is unique because it combines a targeted therapy approach with the chemotherapy drug docetaxel, potentially offering a more focused attack on cancer cells while minimizing damage to healthy cells, unlike standard chemotherapy treatments that affect both cancerous and healthy cells. ^{1 2 8 9 10}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that's spread or can't be surgically removed. They should have had only one prior platinum-based chemo and an anti-PD-(L)1 drug, or up to two targeted therapies if they have certain genomic alterations in their tumors.

Inclusion Criteria

My condition worsened after my last treatment.

My lung cancer is at an advanced stage and cannot be surgically removed.

My lung cancer is non-squamous non-small cell type.

Exclusion Criteria

I have not had another cancer or any remaining cancer from a past diagnosis in the last 3 years.

I haven't had any cancer treatment in the last 3 weeks.

I have a specific respiratory condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sigvotatug vedotin on Days 1 and 15 during each 28-day cycle or docetaxel on Day 1 during each 21-day cycle

Approximately 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Docetaxel
• SGN-B6A

Trial Overview The study compares sigvotatug vedotin (SGN-B6A), a new antibody drug designed to target and kill cancer cells, against docetaxel, an approved anticancer drug. Participants will receive either SGN-B6A on Days 1 and 15 of a 28-day cycle or docetaxel on Day 1 of a 21-day cycle.

Participant Groups

Group I: Experimental Arm Experimental Treatment 1 Intervention

sigvotatug vedotin monotherapy

Group II: Control Arm Active Control 1 Intervention

Docetaxel monotherapy

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

Seagen Inc.

Lead Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials

20

Recruited

4,900+

Findings from Research

In a phase III study involving 274 patients with stage IIIA or locally treatable IIIB non-small-cell lung cancer (NSCLC), neoadjuvant docetaxel treatment resulted in a median survival of 14.8 months compared to 12.6 months in the control group, indicating a potential benefit in overall survival.

Docetaxel was well-tolerated, with 77% of patients completing all planned treatment cycles, although it did cause significant side effects like grade 4 neutropenia in 55% of patients, suggesting that while effective, careful monitoring for toxicity is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel as neoadjuvant therapy for radically treatable stage III non-small-cell lung cancer: a multinational randomised phase III study. Mattson, KV., Abratt, RP., ten Velde, G., et al.[2020]

Docetaxel is a highly effective treatment for advanced non-small-cell lung cancer (NSCLC), showing improved patient quality of life compared to vinorelbine-cisplatin in clinical trials, leading to its FDA approval for this indication.

With a higher binding affinity for beta tubulin than paclitaxel, docetaxel is the only chemotherapy agent approved for both first- and second-line therapy of advanced NSCLC, demonstrating its versatility and efficacy in various treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of docetaxel in advanced non-small-cell lung cancer. Belani, CP., Eckardt, J.[2022]

Docetaxel is a well-tolerated second-line chemotherapy for advanced non-small cell lung cancer (NSCLC) that showed a partial response in 6.3% of patients and stable disease in 25%, with a median survival time of 8.1 months.

Importantly, treatment with docetaxel did not negatively affect the overall quality of life for patients, and it helped alleviate symptoms like shortness of breath and weight loss in many cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doxetaxel in previously treated non-small cell lung cancer patients: clinical efficacy and quality of life. Sirisinha, T., Sirilertrakul, S., Jirajarus, M., et al.[2018]

In two phase III trials involving patients with previously treated non-small cell lung cancer, docetaxel at a dose of 75 mg/m2 significantly improved median survival (7.5 months) compared to best supportive care (4.6 months) and showed a higher 1-year survival rate (37% vs 11%).

Docetaxel at 75 mg/m2 also demonstrated comparable efficacy to other treatments like vinorelbine/ifosfamide, with manageable and predictable adverse events, confirming its role as an effective second-line therapy for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) shows survival and quality-of-life benefits in the second-line treatment of non-small cell lung cancer: a review of two phase III trials. Shepherd, FA., Fossella, FV., Lynch, T., et al.[2019]

In two phase III trials involving patients with previously treated non-small cell lung cancer, docetaxel at a dose of 75 mg/m2 significantly improved median survival (7.5 months) compared to best supportive care (4.6 months) and showed a higher 1-year survival rate (37% vs 11%).

Docetaxel at 75 mg/m2 also demonstrated comparable efficacy to other treatments like vinorelbine/ifosfamide, with manageable and predictable adverse events, confirming its role as an effective second-line therapy for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) shows survival and quality-of-life benefits in the second-line treatment of non-small cell lung cancer: A review of two phase III trials. Shepherd, FA., Fossella, FV., Lynch, T., et al.[2019]

In a study of 182 elderly patients (average age 76) with advanced non-small-cell lung cancer, docetaxel showed a significant improvement in progression-free survival (5.5 months) and response rates (22.7%) compared to vinorelbine (3.1 months and 9.9%, respectively).

While docetaxel did not significantly improve overall survival compared to vinorelbine, it was associated with better disease-related symptom improvement and was generally well tolerated, making it a potential option for standard treatment in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904). Kudoh, S., Takeda, K., Nakagawa, K., et al.[2022]

Docetaxel is effective in treating non-small cell lung cancer (NSCLC) by promoting microtubule assembly, leading to cell cycle arrest and death, and has shown survival benefits in both first- and second-line treatments.

The primary toxicity associated with docetaxel is neutropenia, which can be managed with weekly dosing, while other side effects like peripheral edema and interstitial pneumonitis can be mitigated with premedication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel in the treatment of non-small cell lung carcinoma: an update and analysis. Gubens, MA., Wakelee, HA.[2020]

The combination of docetaxel and cisplatin showed a higher overall response rate in treating non-small-cell lung cancer compared to docetaxel alone, based on a meta-analysis of nine clinical trials involving 1257 patients.

However, this combination therapy also led to a higher incidence of adverse effects, including anemia and nausea, without improving the one-year survival rate compared to docetaxel alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel versus docetaxel plus cisplatin for non-small-cell lung cancer: a meta-analysis of randomized clinical trials. Li, A., Wei, ZJ., Ding, H., et al.[2018]

Docetaxel is an effective treatment for non-small-cell lung cancer, showing response rates of 21% to 38% in previously untreated patients and 20% to 21% in those who had failed prior chemotherapy, with median survival times ranging from 25.2 to 47.0 weeks.

Combining docetaxel with platinum compounds like cisplatin or carboplatin has demonstrated improved response rates (21% to 48%) and tolerability, with ongoing studies evaluating its effectiveness in advanced non-small-cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel in combination with platinums in patients with advanced non-small-cell lung cancer. Belani, CP.[2018]

In a Phase IV study involving 411 Iranian cancer patients, docetaxel (Alvotere) demonstrated an acceptable safety profile, with alopecia being the most common adverse event reported in 41.12% of patients.

The study found that 22.38% of patients experienced severe adverse events (grade 3 or 4), with a notable difference in skin disorders between genders, indicating the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Post-Marketing Surveillance Study to Evaluate the Safety Profile of Alvotere&#9415; (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy. Shahi, F., Vafaeezadeh, F., Ansarinejad, N., et al.[2022]

References

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

Docetaxel as neoadjuvant therapy for radically treatable stage III non-small-cell lung cancer: a multinational randomised phase III study. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Development of docetaxel in advanced non-small-cell lung cancer. [2022]

3. Thailand pubmed.ncbi.nlm.nih.gov

Doxetaxel in previously treated non-small cell lung cancer patients: clinical efficacy and quality of life. [2018]

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

Docetaxel (Taxotere) shows survival and quality-of-life benefits in the second-line treatment of non-small cell lung cancer: a review of two phase III trials. [2019]

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

Docetaxel (Taxotere) shows survival and quality-of-life benefits in the second-line treatment of non-small cell lung cancer: A review of two phase III trials. [2019]

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

Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904). [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Docetaxel in the treatment of non-small cell lung carcinoma: an update and analysis. [2020]

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

Docetaxel versus docetaxel plus cisplatin for non-small-cell lung cancer: a meta-analysis of randomized clinical trials. [2018]

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

Docetaxel in combination with platinums in patients with advanced non-small-cell lung cancer. [2018]

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

A Post-Marketing Surveillance Study to Evaluate the Safety Profile of Alvotere&#9415; (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy. [2022]