DS-1062a vs Docetaxel for Lung Cancer

Not currently recruiting at 254 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, DS-1062a (an experimental treatment) and docetaxel, to determine which is more effective for people with advanced non-small cell lung cancer (NSCLC) who have already tried other treatments. The main goal is to assess the effectiveness and safety of DS-1062a compared to the standard treatment, docetaxel. The study seeks participants with advanced NSCLC that has progressed despite previous treatments. Those treated for advanced NSCLC whose cancer has worsened may qualify for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering access to potentially groundbreaking treatment.

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.

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

Research has shown that DS-1062a is promising in terms of safety for patients with advanced non-small cell lung cancer (NSCLC). In earlier studies, most participants tolerated DS-1062a well. Some experienced side effects, but these were usually mild to moderate, with serious side effects being less common.

Docetaxel, a well-known treatment for various cancers including lung cancer, can cause side effects like low blood cell counts and hair loss. However, doctors are familiar with these effects and know how to manage them.

Both treatments have safety profiles that doctors understand well, enabling them to monitor and manage any side effects during the trial. ^{1 2 3 4 5}

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

Researchers are excited about DS-1062a for lung cancer because it represents a new approach in targeting tumors. Unlike traditional chemotherapy drugs like Docetaxel, which broadly attack rapidly dividing cells, DS-1062a is an antibody-drug conjugate designed to specifically target and deliver its cancer-killing agent directly to the tumor cells. This targeted approach not only has the potential to be more effective but also aims to reduce the side effects typically associated with chemotherapy. By honing in on the cancer cells, DS-1062a offers hope for a more precise and potentially gentler treatment option for lung cancer patients.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

This trial will compare DS-1062a with Docetaxel for treating non-small cell lung cancer (NSCLC). Studies have shown that DS-1062a, also known as datopotamab deruxtecan, significantly improved the time patients lived without their cancer worsening compared to docetaxel in those with advanced or spreading NSCLC. This improvement was especially noticeable in patients with a specific lung cancer cell pattern called nonsquamous histology. Previous patients found that DS-1062a was well tolerated and effective at doses up to 8 mg/kg, showing clear signs of tumor reduction. In contrast, docetaxel is a well-known chemotherapy drug used for various cancers, including NSCLC, but recent studies suggest that DS-1062a might be a more promising treatment for this specific condition. Overall, evidence supports DS-1062a as a potentially more effective treatment option for certain types of lung cancer compared to docetaxel. ^{2 6 7 8 9}

Who Is on the Research Team?

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-01544

Datopotamab Deruxtecan Versus Docetaxel for Previously ... Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04940325

NCT04940325 | Datopotamab Deruxtecan (Dato-DXd, DS ... This study aims to evaluate the efficacy and safety of DS-1062a in participants with metastatic, unresectable NSCLC having progressed on one, but not more than ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT312611

Dose escalation and expansion from the phase I study of ... In this first-in-human study of DS-1062, treatment was well tolerated up to 8 mg/kg, and a dose effect on antitumor activity was observed over 2.0-10.0 mg/kg.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10564307/

First-in-Human, Phase I Dose-Escalation ... - PubMed Central This first-in-human, dose-escalation and dose-expansion study evaluated the safety, tolerability, and antitumor activity of datopotamab deruxtecan ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04484142

NCT04484142 | Study of DS-1062a in Advanced or ... This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03401385

NCT03401385 | First-in-human Study of DS-1062a for ... This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments.

7. mayo.edu mayo.edu/research/clinical-trials/cls-20520569

Study of DS-1062a in Advanced or Metastatic Non-small ... The purpose of this study is to evaluate the effectiveness, pharmacokinetics (PK), and safety of DS-1062a in subjects with advanced or ...

8. jto.org jto.org/article/S1556-0864(21)00322-1/fulltext

OA03.03 Datopotamab Deruxtecan (Dato-DXd; DS-1062 ... DS-1062 has demonstrated promising safety and antitumor efficacy in an ongoing phase 1 study in patients with advanced/ metastatic NSCLC.

9. daiichisankyo.com daiichisankyo.com/media/press_release/detail/index_3182.html

First-in-human results presented for DS-1062, ... First-in-human results presented for DS-1062, an investigational TROP2 targeting ADC, in patients with advanced NSCLC where no standard treatment is available.