Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 3NCT05048797
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
A Phase 3 study testing Trastuzumab Deruxtecan, Cisplatin and Carboplatin in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by AstraZeneca at 130 sites in 20 countries.
Trial summary
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations Read more about this study
- Who is it for?
- Ages 18 to 123 years
- Conditions the study is for
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Trastuzumab Deruxtecan, Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 130 sitesin 20 countries
- Study dates
- 28 Oct 2021to 30 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 123 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants at least 18 years of age
- Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease
- Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
- Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Measurable disease assessed by Investigator based on RECIST 1.1
Show all 9Show fewer
- Protocol-defined adequate organ function including cardiac, renal, hepatic function
- ECOG 0-1
- Having tumour tissue available for central testing
Who cannot join
- Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)
- Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases
- Active autoimmune or inflammatory disorders
- Medical history of myocardial infarction within 6 months prior to randomization
- History of non-infectious pneumonitis/ILD, current or suspected ILD
- Lung-specific intercurrent clinical significant severe illness
- Contraindication to platinum-based doublet chemotherapy or pembrolizumab
Trial locations and contacts
130 sites in 20 countries.
130 sites in 20 countries
China23 sites
Research Site
Beijing, 100142
Research Site
Beijing, 100730
Research Site
Changchun, 130021
Research Site
Changsha, 410008
Research Site
Changsha, 410013
Research Site
Chengdu, 611135
Research Site
Fuzhou, 350014
Research Site
Guangzhou, 510080
Research Site
Hangzhou, 310020
Research Site
Jinan, 250117
Research Site
Kunming, 650101
Research Site
Kunming, 650118
Research Site
Linhai, 317000
Research Site
Nanchang, 330006
Research Site
Nanjing, 210029
Research Site
Shanghai, 200032
Research Site
Shenyang, 110016
Research Site
Shenzhen, 518020
Research Site
Wenzhou, CN-325000
Research Site
Wuhan, 430022
Research Site
Xi'an, 710061
Research Site
Xiamen, 361003
Research Site
Yangzhou, 225001
United States19 sites
Research Site
Anchorage, Alaska, 99508
Research Site
Ann Arbor, Michigan, 48109
Research Site
Basking Ridge, New Jersey, 07920
Research Site
Boston, Massachusetts, 02215
Research Site
Commack, New York, 11725
Research Site
Dallas, Texas, 75246
Research Site
Harrison, New York, 10604
Research Site
Los Alamitos, California, 90720
Research Site
Los Angeles, California, 90048
Research Site
Middletown, New Jersey, 07748
Research Site
Montvale, New Jersey, 07645
Research Site
New Brunswick, New Jersey, 08901
Research Site
New York, New York, 10065
Research Site
Orange, California, 92868
Research Site
Pittsburgh, Pennsylvania, 15232
Research Site
San Francisco, California, 94143
Research Site
Santa Monica, California, 90404
Research Site
Silver Spring, Maryland, 20910
Research Site
Uniondale, New York, 11553
Japan13 sites
Research Site
Chūōku, 104-0045
Research Site
Fukuoka, 812-8582
Research Site
Kashiwa, 277-8577
Research Site
Matsuyama, 791-0280
Research Site
Niigata, 951-8566
Research Site
Okayama, 700-8558
Research Site
Osaka, 541-8567
Research Site
Sakai, 590-0197
Research Site
Sapporo, 060-8638
Research Site
Sendai, 981-0914
Research Site
Sunto-gun, 411-8777
Research Site
Yokohama, 241-8515
Research Site
Yonago-shi, 683-8504
Brazil8 sites
Research Site
Barretos, 14784-400
Research Site
Blumenau, 89010-340
Research Site
Brasília, 70200-730
Research Site
Natal, 59075-740
Research Site
Salvador, 40170-110
Research Site
São Paulo, 01321-001
Research Site
São Paulo, 01327-001
Research Site
Uberlândia, 38408-150
France8 sites
Research Site
Bordeaux, 33000
Research Site
Dijon, 21079
Research Site
Le Mans, 72037
Research Site
Lyon, 69373
Research Site
Marseille, 13915
Research Site
Nantes, 44093
Research Site
Toulouse, 31059
Research Site
Villejuif, 94805
Taiwan8 sites
Research Site
Kaohsiung City, 833
Research Site
Taichung, 40201
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Taipei, 10048
Research Site
Taipei, 235
Research Site
Taipei, TAIWAN
Research Site
Taoyuan, 333
Italy6 sites
Research Site
Milan, 20141
Research Site
Monza, 20090
Research Site
Orbassano, 10043
Research Site
Parma, 43126
Research Site
Roma, 00168
Research Site
Verona, 37134
South Korea6 sites
Research Site
Cheongju-si, 28644
Research Site
Goyang-si, 10408
Research Site
Gyeonggi-do, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Germany5 sites
Research Site
Cologne, 50937
Research Site
Dresden, 01307
Research Site
Mainz, 55131
Research Site
München, 81377
Research Site
Oldenburg, 26121
India5 sites
Research Site
Bangalore, 560027
Research Site
Delhi, 110085
Research Site
Hyderabad, 500032
Research Site
Mumbai, 400012
Research Site
Nashik, 422002
Canada4 sites
Research Site
Brampton, Ontario, L6R 3J7
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Toronto, Ontario, M5G 1Z5
Research Site
Vancouver, British Columbia, V5Z 4E6
Poland4 sites
Research Site
Gdansk, 80-952
Research Site
Olsztyn, 10-357
Research Site
Przemyśl, 37-700
Research Site
Warsaw, 02-781
Spain4 sites
Research Site
L'Hospitalet de Llobregat, 08908
Research Site
Madrid, 28041
Research Site
Málaga, 29730
Research Site
Valencia, 46026
Turkey (Türkiye)4 sites
Research Site
Çankaya, 06680
Research Site
Edirne, 22030
Research Site
Izmir, 35040
Research Site
Kadıkoy/Istanbul, 34722
Hong Kong3 sites
Research Site
Hong Kong, 999077
Research Site
Hong Kong
Research Site
Jordan, 999077
Netherlands3 sites
Research Site
Amsterdam, 1081 HV
Research Site
Groningen, 9700 RB
Research Site
Nijmegen, 6525 GA
Mexico2 sites
Research Site
Mexico City, '14080
Research Site
Mexico City, 03810
About this study
Official title: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
Read the detailed description
Eligible participants will be those diagnosed with unresectable, locally advanced or metastatic histologically documented non-squamous NSCLC with HER2 exons 19 or 20 mutations and who are treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease.
The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) as compared with Standard of Care treatment (Investigator's choice of cisplatin or carboplatin + pembrolizumab + pemetrexed). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse or simply to live longer, compared to patients receiving standard of care treatment. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
- Being tested
- Trastuzumab Deruxtecan, Cisplatin, Carboplatin, Pembrolizumab, Pemetrexed
- Keywords
- DS-8201a, HER2 exon 19 or 20 mutations, ERBB2 gene (coding for the HER2 protein), T-DXd, Trastuzumab Deruxtecan, Locally advanced and unresectable non-squamous NSCLC, Metastatic non-squamous NSCLC, Non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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; T-DXd
Trastuzumab Deruxtecan administered by intravenous infusion
CisplatinDrug
Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
CarboplatinDrug
Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
PembrolizumabDrug
Pembrolizumab administered by intravenous infusion
PemetrexedDrug
Pemetrexed administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Trastuzumab Deruxtecan (T-DXd) Receives: Drug: Trastuzumab Deruxtecan |
| Arm 2 | Active comparator | Standard of Care Treatment (platinum, pemetrexed and pembrolizumab) Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Pembrolizumab; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause.
Measured: Until progression or death, assessed up to approximately 12 months
Secondary outcomes (15)
Overall Survival (OS)
Defined as time from randomization until the date of death due to any cause.
Measured: Until death, assessed up to approximately 28 months.
Progression Free Survival (PFS) by investigator assessment
Defined as time from randomization until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause.
Measured: Until progression, assessed up to approximately 12 months
Objective Response Rate (ORR)
Defined as the proportion of participants who have a complete response (CR) or partial response (PR) as assessed by Blinded Independent Central Review (BICR) and investigator according to RECIST 1.1
Measured: Until progression, assessed up to approximately 12 months
Duration of Response (DoR)
Defined as the time from the date of first documented response until date of documented progression as assessed by Blinded Independent Central Review (BICR) and investigator assessment according to RECIST 1.1.
Measured: Until progression, assessed up to approximately 12 months
Time to second progression or death (PFS2)
Defined as the time from randomization until second progression on next-line of treatment as assessed by investigator at the local site using assessments conducted per local standard clinical practice, or death due to any cause.
Measured: Assessed up to approximately 20 months
Landmark analysis of PFS (PFS12)
Defined as proportion of participants alive and progression-free at 12 months, as assessed by Blinded Independent Central Review (BICR) and investigator.
Measured: Assessed up to approximately 12 months
Landmark analysis of OS (OS24)
Defined as proportion of participants alive at 24 months
Measured: Assessed up to approximately 24 months
Central Nervous System (CNS) - Progression Free Survival (PFS)
Defined as time from randomization until Central Nervous System (CNS) progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR) or death due to any cause in the absence of CNS progression.
Measured: Until CNS progression or death, assessed up to approximately 12 months
Safety and tolerability of T-DXd versus Standard of Care treatment
Assessed by the occurrence of AEs, SAEs, and changes from baseline in laboratory parameters, vital signs, ECG, and ECHO/MUGA scan results.
Measured: Until progression or death, assessed up to approximately 28 months
Pharmacokinetics (PK) of T-DXd, total anti-HER2 antibody and DXd in serum
Serum concentration of T-DXd, total anti-HER2 antibody and DXd.
Measured: Up to cycle 4, approximately 12 weeks
Immunogenicity of T-DXd
Presence of anti-drug antibodies (ADAs) for T-DXd.
Measured: Until progression, assessed up to approximately 13 months
Patient-reported pulmonary symptoms associated with Non-Small Cell Lung Cancer
Time to sustained deterioration in pulmonary symptoms (cough, dyspnea, chest pain) while on treatment using the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ).
Measured: Until progression, assessed up to approximately 13 months
Patient-reported tolerability of T-DXd described using symptomatic AEs
Symptomatic AEs: Descriptive summary of the proportion of participants reporting symptomatic AEs while on treatment, as assessed by the Patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and items from the European Organisation for Research and Treatment of Cancer (EORTC) Item Library.
Measured: Until progression, assessed up to approximately 13 months
Patient-reported tolerability of T-DXd described using overall side-effect bother
Overall side-effect bother: Descriptive summary of the proportion of participants reporting overall side-effect bother on the Patient's Global Impression of Treatment Tolerability (PGI-TT) while on treatment.
Measured: Until progression, assessed up to approximately 13 months
Patient-reported tolerability of T-DXd described using physical function
Physical Function: The proportion of participants with maintained or improved physical function while on treatment, based on the European Organisation for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC-QLQ-C30) physical functioning scale.
Measured: Until progression, assessed up to approximately 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start28 Oct 2021
- Primary completion9 Jun 2026
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study consists of two open-label treatment arms: Arm 1: Trastuzumab Deruxtecan Arm 2: Standard of Care treatment (platinum, pemetrexed and pembrolizumab)
- Masking
- None (open label)
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048797
- Sponsor's protocol ID
- D967SC00001
- Other IDs
- 2023-503674-20-00, 2021-000634-33, 2023
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
- ClinicalTrials.gov ID
- NCT05048797
- Acronym / sponsor ID
- D967SC00001
- Keywords
- DS-8201a, HER2 exon 19 or 20 mutations, ERBB2 gene (coding for the HER2 protein), T-DXd, Trastuzumab Deruxtecan, Locally advanced and unresectable non-squamous NSCLC, Metastatic non-squamous NSCLC, Non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 454 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
Detailed description
Eligible participants will be those diagnosed with unresectable, locally advanced or metastatic histologically documented non-squamous NSCLC with HER2 exons 19 or 20 mutations and who are treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease.
The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) as compared with Standard of Care treatment (Investigator's choice of cisplatin or carboplatin + pembrolizumab + pemetrexed). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse or simply to live longer, compared to patients receiving standard of care treatment. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study consists of two open-label treatment arms: Arm 1: Trastuzumab Deruxtecan Arm 2: Standard of Care treatment (platinum, pemetrexed and pembrolizumab)
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Trastuzumab DeruxtecanTrastuzumab Deruxtecan (T-DXd) |
| Arm 2 | Active comparator | Drug: Cisplatin, Drug: Carboplatin, Drug: Pembrolizumab, Drug: PemetrexedStandard of Care Treatment (platinum, pemetrexed and pembrolizumab) |
Who may qualify
- Ages
- 18 to 123 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants at least 18 years of age
- Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease
- Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
- Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
- Left ventricular ejection fraction (LVEF) ≥ 50%
Key exclusion criteria (7 listed)
- Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)
- Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases
- Active autoimmune or inflammatory disorders
- Medical history of myocardial infarction within 6 months prior to randomization
- History of non-infectious pneumonitis/ILD, current or suspected ILD
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; T-DXdTrastuzumab Deruxtecan administered by intravenous infusion | Drug | Arm 1 |
| CisplatinInvestigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion | Drug | Arm 2 |
| CarboplatinInvestigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion | Drug | Arm 2 |
| PembrolizumabPembrolizumab administered by intravenous infusion | Drug | Arm 2 |
| PemetrexedPemetrexed administered by intravenous infusion | Drug | Arm 2 |
Primary outcome
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Time frame: Until progression or death, assessed up to approximately 12 months
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause.
15 secondary outcomes
Overall Survival (OS)
Time frame: Until death, assessed up to approximately 28 months.
Progression Free Survival (PFS) by investigator assessment
Time frame: Until progression, assessed up to approximately 12 months
Objective Response Rate (ORR)
Time frame: Until progression, assessed up to approximately 12 months
Duration of Response (DoR)
Time frame: Until progression, assessed up to approximately 12 months
Time to second progression or death (PFS2)
Time frame: Assessed up to approximately 20 months
Landmark analysis of PFS (PFS12)
Time frame: Assessed up to approximately 12 months
Landmark analysis of OS (OS24)
Time frame: Assessed up to approximately 24 months
Central Nervous System (CNS) - Progression Free Survival (PFS)
Time frame: Until CNS progression or death, assessed up to approximately 12 months
Safety and tolerability of T-DXd versus Standard of Care treatment
Time frame: Until progression or death, assessed up to approximately 28 months
Pharmacokinetics (PK) of T-DXd, total anti-HER2 antibody and DXd in serum
Time frame: Up to cycle 4, approximately 12 weeks
Immunogenicity of T-DXd
Time frame: Until progression, assessed up to approximately 13 months
Patient-reported pulmonary symptoms associated with Non-Small Cell Lung Cancer
Time frame: Until progression, assessed up to approximately 13 months
Patient-reported tolerability of T-DXd described using symptomatic AEs
Time frame: Until progression, assessed up to approximately 13 months
Patient-reported tolerability of T-DXd described using overall side-effect bother
Time frame: Until progression, assessed up to approximately 13 months
Patient-reported tolerability of T-DXd described using physical function
Time frame: Until progression, assessed up to approximately 13 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Lung Cancer Study Locator details (for US)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
The record lists no contact. Use the official record to reach the sponsor.
130 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab Deruxtecan, Cisplatin and Carboplatin in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by AstraZeneca at 130 sites in 20 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 7 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in China, United States, Japan, Brazil, France and 15 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (time frame: Until progression or death, assessed up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.