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Advanced Non-small Cell Lung CancerPhase 1/2NCT04818333

A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

A Phase 1/2 study testing SHR-A1811 in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Non-small Cell Lung Cancer
What is being tested?
SHR-A1811
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
1 siteChina
Study dates
23 Apr 2021to Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Able and willing to provide a written informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
  • has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
  • There is at least one measurable lesion according to RECIST V1.1 criteria

Who cannot join

  • Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
  • Has received HER2 antibody drug conjugates,
  • Central nervous system metastasis or meningeal metastasis with clinical symptoms
  • Has active infection requiring systemic treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation

Being tested
SHR-A1811

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A1811Drug

    Phase 1 Drug: SHR-A1811 There are four pre-defined dose regimens . Subjects will be enrolled with an initial dose Phase 2 Drug: SHR-A1811 Doses will be determined from Phase 1

Study groups in NCT04818333
Study groupRoleWhat they receive
SHR-A1811ExperimentalSHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment
Receives: Drug: SHR-A1811

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811

    Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)

    Measured: From Day 1 to90 days after last dose ，appropriately to 3 years

  2. Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811

    Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)

    Measured: From Day 1 to90 days after last dose ，appropriately to 3 years

  3. Phase1: Maximum tolerated dose (MTD)

    Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment

    Measured: 12 months

  4. Phase 1: Recommended Phase 2 dose (RP2D)

    RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained

    Measured: 12 months

  5. Phase2:ObjectiveResponse Rate (ORR)

    As assessed by RECIST v1.1 , as assessed by independent review committee (IRC)

    Measured: Subjects were evaluated on tumor imaging every 6 weeks after treatment initiation and every 12 weeks after 54 weeks, until imaging progression, initiation of new antitumor therapy, loss of follow-up, and death，appropriately to 3 years

Secondary outcomes (9)

  1. Phase 1：PK parameter ：Tmax of SHRA1811

    Time to maximal concentration (Tmax) of SHR-A1811

    Measured: appropriately to 3 years

  2. Phase1:PK parameter: Cmax of SHR-A1811

    Maximal concentration (Cmax) of SHR-A1811

    Measured: appropriately to 3 years

  3. Phase1:PK parameter: AUC0-t of SHR-A1811

    AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811

    Measured: appropriately to 3 years

  4. Phase1:Immunogenicity of SHR-A1811

    Including anti-drug antibody and/or neutralizing antibody

    Measured: Immunogenicity sample collection time points include: within 30 min before administration of C1D1, C2D1, C3D1, C4D1, C6D1 and C8D1 starting from cycle 11 only in every 3 cycles ,appropriately to 3 years

  5. Phase2:Progression Free Survival (PFS)

    As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator

    Measured: appropriately to 3 years

  6. Phase2:ObjectiveResponse Rate (ORR)

    As assessed by RECIST v1.1 , as assessed by investigator

    Measured: appropriately to 3 years

  7. Phase2:Duration of response (DOR)

    As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator

    Measured: appropriately to 3 years

  8. Phase2:Disease control rate (DCR)

    As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator

    Measured: appropriately to 3 years

  9. Phase2:Overall survival (OS)

    Measured: Approximately 5 years after last subject enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start23 Apr 2021
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm study of SHR-A1811
Masking
None (open label)
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04818333
Sponsor's protocol ID
SHR-A1811-I-103
Status last verified
Jun 2024
First submitted
25 Mar 2021
Last updated
13 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li Z, Wang Y, Sun Y, Wang L, Li X, Sun L, He Z, Yang H, Wang Y, Wang Q, Song Z, Hong W, Wang Y, Xia G, Yu Y, Peng M, Song Y, Wang D, Meng R, Fang J, Luo Y, Liang W, Hu S, Wang Z, Song K, Li Y, Yang L, Shi W, Lu S. Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025 Apr;26(4):437-446. doi: 10.1016/S1470-2045(25)00012-9. Epub 2025 Feb 25.

    PubMed 40020696

  • Li Z, Song Z, Hong W, Yang N, Wang Y, Jian H, Liang Z, Hu S, Peng M, Yu Y, Wang Y, Jiao Z, Zhao K, Song K, Li Y, Shi W, Lu S. SHR-A1811 (antibody-drug conjugate) in advanced HER2-mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study. Signal Transduct Target Ther. 2024 Jul 15;9(1):182. doi: 10.1038/s41392-024-01897-y.

    PubMed 39004647

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A1811 in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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?

Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811 (time frame: From Day 1 to90 days after last dose ，appropriately to 3 years). The study lists 5 primary outcomes in all. 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 NCT04818333, which also lists 2 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 13 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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