DS-1062a for Lung Cancer

Not currently recruiting at 106 trial locations

Overseen By (Asia sites) Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Daiichi Sankyo, Inc.

Must be taking: Targeted therapy

Must not be taking: Corticosteroids, Anticonvulsants

Disqualifiers: CNS metastases, Cardiovascular disease, ILD, 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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment, DS-1062a (an experimental drug), for individuals with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes. The trial evaluates the drug's efficacy and its behavior in the body. Suitable candidates have advanced NSCLC with certain genetic alterations and have experienced disease progression after previous treatments. This study targets individuals who have tried other therapies and seek new options. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to explore new treatment possibilities.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have progressed on or after their most recent treatment for lung cancer, which might imply some changes to your current treatment plan. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that DS-1062a is likely to be safe for humans?

Research has shown that DS-1062a was tested in people with non-small cell lung cancer (NSCLC) who did not respond to other treatments. In these studies, DS-1062a was generally well-tolerated at doses up to 8 mg/kg, with most people not experiencing severe side effects at these levels. Patients demonstrated some tumor reduction with doses between 2.0 to 10.0 mg/kg, suggesting the treatment can be effective without causing significant problems.

This trial tests a dose of 6.0 mg/kg, which falls within the safe range identified in earlier studies, indicating it is likely to be well-tolerated by participants. ^{1 2 3 4 5}

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

Unlike the standard treatments for lung cancer, which often include chemotherapy, radiation, and targeted therapies like EGFR inhibitors, DS-1062a is a novel drug that specifically targets a protein called TROP2. This protein is frequently overexpressed in many lung cancers, making DS-1062a a potentially more precise treatment option. Researchers are excited because this targeted approach could lead to fewer side effects and better outcomes compared to less specific treatments. Additionally, by directly targeting TROP2, DS-1062a may be effective in patients who have not responded well to existing therapies.

What evidence suggests that DS-1062a might be an effective treatment for lung cancer?

Research has shown that DS-1062a, also known as datopotamab deruxtecan, may effectively treat advanced non-small cell lung cancer (NSCLC). One study found that DS-1062a helped patients live longer without their cancer worsening compared to the usual treatment, docetaxel. Early tests demonstrated that DS-1062a was safe in doses up to 8 mg/kg. This trial will specifically evaluate the effectiveness and safety of DS-1062a at a dose of 6.0 mg/kg. The drug works by directly delivering chemotherapy to cancer cells, potentially increasing effectiveness and reducing side effects. Overall, early findings suggest DS-1062a could be a valuable option for patients with advanced lung cancer, especially those with specific genetic changes. ^{6 7 8 9 10}

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) and specific genomic alterations like EGFR, ALK, ROS1 can join. They must have measurable disease progression after recent treatment and be in good physical condition (ECOG PS of 0-1). Those with certain heart conditions, prior treatments targeting topoisomerase I or TROP2, active brain metastases requiring steroids/anticonvulsants, severe lung issues like ILD/pneumonitis are excluded.

Inclusion Criteria

My cancer has a specific genetic change (like EGFR or ALK).

I have not taken osimertinib but have been checked for the EGFR T790M mutation after my last treatment.

I meet the treatment criteria for advanced or metastatic non-small cell lung cancer.

Exclusion Criteria

I have no other cancers, or any I had were treated and have been clear for over 3 years.

I have or had lung inflammation that needed steroids, or it might be present but not confirmed.

I have been treated with drugs targeting topoisomerase I or TROP2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6.0 mg/kg of DS-1062a for advanced or metastatic NSCLC

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

What Are the Treatments Tested in This Trial?

Interventions

• DS-1062a

Trial Overview The trial is testing DS-1062a's effectiveness and safety for NSCLC patients with actionable genetic changes. It will assess how the body processes the drug and monitor any improvements in cancer symptoms or size.

How Is the Trial Designed?

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

Participants will receive 6.0 mg/kg of DS-1062a

Who Is Running the Clinical Trial?

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

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

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

Surgery is a potentially curative treatment for non-small cell lung cancer (NSCLC) in stages I and II, and stage IIIA T3 tumors may also be operable with the help of preoperative chemotherapy to downstage the disease.

Postoperative chemotherapy is generally not recommended for stages I, II, and IIIA NSCLC, but cisplatin-based chemotherapy combined with radiotherapy is effective for stage IIIA N2, stage IIIB, and metastatic stage IV NSCLC, improving survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of non-small cell lung cancer according to staging--an update. Lam, WK.[2019]

Cisplatin-based chemotherapy is preferred for treating advanced nonsmall cell lung cancer, with carboplatin as an alternative for patients with contraindications; nonplatinum regimens are also available for those who cannot tolerate platinum-based treatments.

There is no evidence that higher doses of cisplatin improve survival compared to standard doses, and a minimum of four to six cycles of chemotherapy is recommended for patients who respond well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First- and second-line therapy for advanced nonsmall cell lung cancer. Sculier, JP., Moro-Sibilot, D.[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. 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 (Dato-DXd)

4. 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.

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. 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 ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.9619

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.

9. 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 ...

10. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5367

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