Non-small Cell Lung CancerPhase 3NCT06671379
A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC
A Phase 3 study testing SHR-A2009 monotherapy and platinum-based dual-agent chemotherapy in people with Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- SHR-A2009 monotherapy and platinum-based dual-agent chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2024to Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old (inclusive), Female or male
- Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
- Previously treated by EGFR-TKI；
- At least one measurable tumor lesion according to RECIST v1.1
- ECOG performance score of 0-1;
- Expected survival time ≥ 12 weeks;
- Adequate bone marrow and organ function
- Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
Who cannot join
- Subjects with active central nervous system (CNS) metastases.
- Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
- Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
- Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
- Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
- Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
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- Serious cardiovascular disease
- Presence of severe infection within 4 weeks prior to first dose of study drug
- Arterial/venous thrombotic events within 3 months prior to the first study dose
- History of immunodeficiency, including a positive HIV test
- Presence of active hepatitis B or C;
- History of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- SHR-A2009 monotherapy, platinum-based dual-agent chemotherapy
- 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.
SHR-A2009 monotherapyDrug
SHR-A2009 monotherapy ，SHR-A2009 will be administered intravenously
platinum-based dual-agent chemotherapyDrug
Pemetrexed combined with carboplatin or cisplatin, after four cycles of combination, pemetrexed was continued as a single agent，all drugs will be administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2009 monotherapy | Experimental | Not described Receives: Drug: SHR-A2009 monotherapy |
| platinum-based dual-agent chemotherapy | Active comparator | Not described Receives: Drug: platinum-based dual-agent chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
Measured: Up to approximately 32 months
Secondary outcomes (5)
overall survival (OS)
Measured: Up to approximately 32 months
Progression Free Survival(PFS by investigator)
Measured: Up to approximately 32 months
Duration of response(DoR，by BICR and investigator )
Measured: Up to approximately 32 months
Disease control rate（DCR，by BICR and investigator）
Measured: Up to approximately 32 months
Incidence of AEs
Measured: from Day1 to 40 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start29 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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
- Masking
- None (open label)
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671379
- Sponsor's protocol ID
- SHR-A2009-301
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu CR, Zhang Y, Lin G, Wang H, Wang Q, Huang D, Yu Y, Zhou J, Zhong H, Wu L, Liu L, Duan J, He Z, Luo Y, Liu H, Chen B, Yu X, Xue F, Chu Q, Guo S, Yang R, Zhong J, Liu H, Sun L, Dong X, Su H, Zhang P, Yang B, He S, Ji Y, Wan L, Han X, Zhang J, Qiu F, Yang L, Shi W, Wu YL; HERON-Lung01 Investigators. Ruzaltatug rezetecan versus chemotherapy for EGFR-mutated advanced non-small-cell lung cancer progressing after EGFR tyrosine kinase inhibitor therapy (HERON-Lung01): interim analysis of a randomised, open-label, phase 3 trial in China. Lancet. 2026 Oct 26:S0140-6736(26)01899-4. doi: 10.1016/S0140-6736(26)01899-4. Online ahead of print.
PubMed 42933457
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
- ClinicalTrials.gov ID
- NCT06671379
- Acronym / sponsor ID
- SHR-A2009-301
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Nov 2024 (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.
This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-A2009 monotherapy | Experimental | Drug: SHR-A2009 monotherapy |
| platinum-based dual-agent chemotherapy | Active comparator | Drug: platinum-based dual-agent chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years old (inclusive), Female or male
- Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
- Previously treated by EGFR-TKI；
- At least one measurable tumor lesion according to RECIST v1.1
- ECOG performance score of 0-1;
Key exclusion criteria (12 listed)
- Subjects with active central nervous system (CNS) metastases.
- Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
- Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
- Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
- Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
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 |
|---|---|---|
| SHR-A2009 monotherapySHR-A2009 monotherapy ，SHR-A2009 will be administered intravenously | Drug | SHR-A2009 monotherapy |
| platinum-based dual-agent chemotherapyPemetrexed combined with carboplatin or cisplatin, after four cycles of combination, pemetrexed was continued as a single agent，all drugs will be administered intravenously | Drug | platinum-based dual-agent chemotherapy |
Primary outcome
Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
Time frame: Up to approximately 32 months
5 secondary outcomes
overall survival (OS)
Time frame: Up to approximately 32 months
Progression Free Survival(PFS by investigator)
Time frame: Up to approximately 32 months
Duration of response(DoR，by BICR and investigator )
Time frame: Up to approximately 32 months
Disease control rate（DCR，by BICR and investigator）
Time frame: Up to approximately 32 months
Incidence of AEs
Time frame: from Day1 to 40 days after last dose
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 19 Mar 2026.
- Derived from this study: PubMed 42933457Xu CR, Zhang Y, Lin G, Wang H, Wang Q, Huang D, Yu Y, Zhou J, Zhong H, Wu L, Liu L, Duan J, He Z, Luo Y, Liu H, Chen B, Yu X, Xue F, Chu Q, Guo S, Yang R, Zhong J, Liu H, Sun L, Dong X, Su H, Zhang P, Yang B, He S, Ji Y, Wan L, Han X, Zhang J, Qiu F, Yang L, Shi W, Wu YL; HERON-Lung01 Investigators. Ruzaltatug rezetecan versus chemotherapy for EGFR-mutated advanced non-small-cell lung cancer progressing after EGFR tyrosine kinase inhibitor therapy (HERON-Lung01): interim analysis of a randomised, open-label, phase 3 trial in China. Lancet. 2026 Oct 26:S0140-6736(26)01899-4. doi: 10.1016/S0140-6736(26)01899-4. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A2009 monotherapy and platinum-based dual-agent chemotherapy in people with Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
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 8 inclusion and 12 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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) assessed by BICR according to RECIST v1.1 (time frame: Up to approximately 32 months). 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 NCT06671379, which also lists 1 linked publication.
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 19 Mar 2026.