DS-1062a vs Docetaxel for Lung Cancer

Recruiting at 208 trial locations

Overseen By Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Daiichi Sankyo

Must not be taking: Corticosteroids, Anticonvulsants, Topoisomerase I, TROP2

Disqualifiers: Small-cell lung cancer, Brain metastases, Cardiac disease, ILD, 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: 1

Duration: Up to 43 months

590 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

Will I have to stop taking my current medications?

The trial mentions an 'adequate treatment washout period' before randomization, which suggests you may need to stop certain medications before starting the trial. However, the specific medications that need to be stopped are not detailed in the provided information.

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, especially for those who have already received other treatments. In clinical trials, patients treated with Docetaxel lived longer and had better outcomes compared to those who received only supportive care. ^{1 2 3 4 5}

What safety information is available for Docetaxel in treating lung cancer?

Docetaxel has been studied in several trials for lung cancer, showing side effects like hair loss, fluid retention, infusion reactions, low white blood cell count, nail changes, and rash. Taking dexamethasone can help reduce some of these side effects. ^{1 2 3 6 7}

What makes the drug DS-1062a unique compared to other lung cancer treatments?

DS-1062a is a novel treatment being compared to docetaxel, which is a well-established drug for lung cancer with a high binding affinity to its target, beta tubulin. Docetaxel is known for its effectiveness in both first- and second-line therapy for advanced non-small-cell lung cancer (NSCLC), and DS-1062a is being studied to see if it offers any advantages over this standard treatment. ^{1 2 6 8 9}

Research Team

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

Adults over 18 with advanced or metastatic non-small cell lung cancer (NSCLC) who've had previous treatment can join. They must not be pregnant, agree to use birth control, and have a life expectancy of at least 3 months. People with certain heart conditions, adequate organ function, and no severe allergies to the drugs being tested are eligible.

Inclusion Criteria

Sign and date the inform consent form (ICF) prior to the start of any study specific qualification procedures

I can provide a recent biopsy or have tissue samples from the last 2 years.

Your disease can be measured using a specific method called RECIST v1.1.

Exclusion Criteria

You have had serious allergic reactions to the study drug DS-1062a, docetaxel, or other similar drugs in the past.

I do not have substance abuse issues or significant heart or mental health conditions.

My NSCLC can be treated with local therapy only.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DS-1062a or docetaxel for advanced or metastatic NSCLC

Up to 43 months

Cycle 1: Day 1, 2, 4, 8, 15; Cycles 2, 3, 4, 6, 8: Day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

35 days after last study dose

Treatment Details

Interventions

• Docetaxel
• DS-1062a

Trial Overview The trial is testing DS-1062a against Docetaxel in patients with NSCLC who may also have specific genetic changes in their tumors. It will look at how well these treatments work, their safety profiles, and how the body processes them.

Participant Groups

Group I: DS-1062a 6.0 mg/kg Experimental Treatment 1 Intervention

Participants will be randomized to receive 6.0 mg/kg of DS-1062a.

Group II: Docetaxel 75 mg/m^2 Active Control 1 Intervention

Participants will be randomized to receive 75 mg/m\^2 docetaxel.

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?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Lead Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

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 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]

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 phase II study involving 40 patients with non-small-cell lung cancer (NSCLC) who had previously failed chemotherapy, the combination of monthly docetaxel and weekly gemcitabine showed a response rate of 32.5%, indicating its efficacy as a second-line treatment.

The treatment was generally safe, with severe non-hematologic toxicities being infrequent, although significant hematologic toxicities like grade 4 neutropenia were observed in 23 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: a phase II trial. Spiridonidis, CH., Laufman, LR., Carman, L., et al.[2022]

References

1. 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]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Randomised, multicentre phase II study assessing two doses of docetaxel (75 or 100 mg/m2) as second-line monotherapy for non-small-cell lung cancer. [2022]

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. England pubmed.ncbi.nlm.nih.gov

Taxotere: Clinical Trials in Non-Small Cell Lung Cancer. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin as second-line chemotherapy for advanced non-small cell lung cancer. [2018]

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

Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: a phase II trial. [2022]

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

Docetaxel (Taxotere) as a single agent and in combination chemotherapy for the treatment of patients with advanced non-small cell lung cancer. [2018]