Non-Small Cell Lung CancerPhase 2DESTINY-Lung01NCT03505710
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
A Phase 2 study testing Trastuzumab deruxtecan in people with Non-Small Cell Lung Cancer, run by Daiichi Sankyo at 21 sites in 5 countries.
Trial summary
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Trastuzumab deruxtecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 21 May 2018to 17 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20 years old in Japan, ≥18 years old in other countries
- Pathologically documented unresectable and/or metastatic non-squamous NSCLC
- Has relapsed from or is refractory to standard treatment or for which no standard treatment is available
- For Cohort 1 and Cohort 1a: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent, from an archival tumor tissue sample
- For Cohort 2 only: Participant has any known documented activating HER2 mutation from an archival tumor tissue sample analyzed by CLIA laboratory or equivalent. Note: HER2 mutation documented only from a liquid biopsy sample cannot be used for enrollment.
- Presence of at least 1 measurable lesion assessed by the investigator and based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Show all 9Show fewer
- Is willing and able to provide an adequate archival tumor tissue sample
- Is willing to undergo a tissue biopsy, after the completion of the most recent treatment regimen
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
Who cannot join
- Had been previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors
- For Cohort 1 and Cohort 1a: Has known HER2 mutation
- Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out due to imaging at screening
- Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to > 450 millisecond (ms) in males and > 470 ms in females
- Has a medical history of clinically significant lung disease
Show all 11Show fewer
- Is suspected to have certain other protocol-defined diseases based on imaging at screening period
- Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
- safety or well-being of the participant or offspring
- safety of study staff
- analysis of results
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado Hospital
Aurora, Colorado, 80045
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of California San Diego (UCSD)
La Jolla, California, 92093
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Washington
Seattle, Washington, 98109
Washington University School of Medicine at St. Louis
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
France5 sites
Centre Leon Berard
Lyon, Rhne, 69008
Hôpital Nord - CHU Marseille
Marseille, 12915
CHU Larrey
Toulouse, 31059
Hôpital Larrey, CHU-Toulouse
Toulouse, 31059
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94805
Japan4 sites
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Shizuoka Cancer Center
Nakatogari, Sunto-gun, 411-8777
Kindai University Hospital
Ōsaka-sayama, Osaka, 589-8511
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Hospital 12 de Octubre
Madrid, 28041
About this study
Official title: A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC) (DESTINY-Lung01)
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Trastuzumab deruxtecan
- Keywords
- HER2 over-expression, HER2 mutation, Unresectable or metastatic, Non-squamous, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecanDrug
Also called DS-8201a, Experimental product
Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: HER2 Overexpressing | Experimental | Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Receives: Drug: Trastuzumab deruxtecan |
| Cohort 1a: HER2 Overexpressing | Experimental | Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Receives: Drug: Trastuzumab deruxtecan |
| Cohort 2: HER2 Mutated | Experimental | Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Receives: Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported.
Measured: From screening, up to 36 months (data cut-off)
Secondary outcomes (5)
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported.
Measured: From screening, up to 36 months (data cut-off)
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported.
Measured: From screening to documented tumor progression or death from any cause, up to 36 months (data cut-off)
Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported.
Measured: From date of enrollment to first objective radiographic tumor progression or death from any cause,, up to 36 months (data cut-off)
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Measured: From date of enrollment to death from any cause, up to 36 months (data cut-off)
Percentage of Participants With Disease Control Rate (DCR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. Confirmation of CR/PR was required. DCR based on independent central review and investigator assessment is reported.
Measured: From first dose, up to 36 months (data cut-off)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start21 May 2018
- Primary completion3 May 2021
- Study completion17 Apr 2024
Why it stopped: Last participant transitioned to alternative study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd., AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Global Team Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505710
- Sponsor's protocol ID
- DS8201-A-U204
- Other IDs
- 2017-004781-94, JapicCTI-183916, 2017
- Acronym
- DESTINY-Lung01
- Status last verified
- May 2025
- First submitted
- 13 Apr 2018
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
Smit EF. Trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer: a plain language summary of the DESTINY-Lung01 study. Future Oncol. 2024;20(27):1961-1971. doi: 10.1080/14796694.2024.2355724. Epub 2024 Jul 16.
PubMed 39012221Smit EF, Felip E, Uprety D, Nagasaka M, Nakagawa K, Paz-Ares Rodriguez L, Pacheco JM, Li BT, Planchard D, Baik C, Goto Y, Murakami H, Saltos A, Pereira K, Taguchi A, Cheng Y, Yan Q, Feng W, Tsuchihashi Z, Janne PA. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol. 2024 Apr;25(4):439-454. doi: 10.1016/S1470-2045(24)00064-0.
PubMed 38547891Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazieres J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Perol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Janne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. doi: 10.1056/NEJMoa2112431. Epub 2021 Sep 18.
PubMed 34534430
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC) (DESTINY-Lung01)
- ClinicalTrials.gov ID
- NCT03505710
- Acronym / sponsor ID
- DESTINY-Lung01 / DS8201-A-U204
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- HER2 over-expression, HER2 mutation, Unresectable or metastatic, Non-squamous, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Last participant transitioned to alternative study.
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd., AstraZeneca
- Study start
- 21 May 2018 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: HER2 Overexpressing | Experimental | Drug: Trastuzumab deruxtecanParticipants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). |
| Cohort 1a: HER2 Overexpressing | Experimental | Drug: Trastuzumab deruxtecanParticipants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). |
| Cohort 2: HER2 Mutated | Experimental | Drug: Trastuzumab deruxtecanParticipants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥20 years old in Japan, ≥18 years old in other countries
- Pathologically documented unresectable and/or metastatic non-squamous NSCLC
- Has relapsed from or is refractory to standard treatment or for which no standard treatment is available
- For Cohort 1 and Cohort 1a: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent, from an archival tumor tissue sample
- For Cohort 2 only: Participant has any known documented activating HER2 mutation from an archival tumor tissue sample analyzed by CLIA laboratory or equivalent. Note: HER2 mutation documented only from a liquid biopsy sample cannot be used for enrollment.
Key exclusion criteria (11 listed)
- Had been previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors
- For Cohort 1 and Cohort 1a: Has known HER2 mutation
- Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out due to imaging at screening
- Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to > 450 millisecond (ms) in males and > 470 ms in females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab deruxtecanAlso: DS-8201a, Experimental productAntibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. | Drug | Cohort 1: HER2 Overexpressing, Cohort 1a: HER2 Overexpressing, Cohort 2: HER2 Mutated |
Primary outcome
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Time frame: From screening, up to 36 months (data cut-off)
The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported.
5 secondary outcomes
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Time frame: From screening, up to 36 months (data cut-off)
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Time frame: From screening to documented tumor progression or death from any cause, up to 36 months (data cut-off)
Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Time frame: From date of enrollment to first objective radiographic tumor progression or death from any cause,, up to 36 months (data cut-off)
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Time frame: From date of enrollment to death from any cause, up to 36 months (data cut-off)
Percentage of Participants With Disease Control Rate (DCR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Time frame: From first dose, up to 36 months (data cut-off)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39012221Smit EF. Trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer: a plain language summary of the DESTINY-Lung01 study. Future Oncol. 2024;20(27):1961-1971. doi: 10.1080/14796694.2024.2355724. Epub 2024 Jul 16.
- Derived from this study: PubMed 38547891Smit EF, Felip E, Uprety D, Nagasaka M, Nakagawa K, Paz-Ares Rodriguez L, Pacheco JM, Li BT, Planchard D, Baik C, Goto Y, Murakami H, Saltos A, Pereira K, Taguchi A, Cheng Y, Yan Q, Feng W, Tsuchihashi Z, Janne PA. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol. 2024 Apr;25(4):439-454. doi: 10.1016/S1470-2045(24)00064-0.
- Derived from this study: PubMed 34534430Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazieres J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Perol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Janne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. doi: 10.1056/NEJMoa2112431. Epub 2021 Sep 18.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Team Leader study director
Daiichi Sankyo
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab deruxtecan in people with Non-Small Cell Lung Cancer, run by Daiichi Sankyo at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, France, Japan, Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) (time frame: From screening, up to 36 months (data cut-off)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505710, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.