DS-1062a for Lung Cancer

Recruiting at 85 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

137 Participants Needed

Trial Summary

What is the purpose of this trial?

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 known actionable genomic alterations.

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.

What makes the drug DS-1062a unique for treating lung cancer?

The drug DS-1062a is unique for treating lung cancer because it is a novel therapy that may offer a different mechanism of action compared to traditional platinum-based chemotherapies, which are commonly used for advanced non-small cell lung cancer. While standard treatments often involve cisplatin or carboplatin, DS-1062a could provide an alternative for patients who cannot tolerate these options or have not responded to them. ^{1 2 3 4 5}

Research Team

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

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

First- and second-line therapy for advanced nonsmall cell lung cancer. [2018]

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

The integration of newer agents into neoadjuvant therapy. [2007]

3. Australia pubmed.ncbi.nlm.nih.gov

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

4. Ireland pubmed.ncbi.nlm.nih.gov

A phase II trial of combined chemotherapy and surgery in stage IIIA non-small cell lung cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Treatment of advanced non-small-cell lung cancer patients with ECOG performance status 2: results of an European Experts Panel. [2020]