Asset profile

Gemcitabine

Small molecule

Approvedregulatory verdict

Evidence outlook

Approved — HR+/HER2- Metastatic Breast Cancer, Non-Small Cell Lung Cancer

Regulatory approval supersedes design-level evidence grading — the trials behind approval are preserved below as the drug's evidence history.

How the evidence outlook works ↗

Upcoming events

(42 total)

Estimated primary-completion dates from ClinicalTrials.gov — registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (7)
August 2026 (1)
Phase 2Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2026-08-30 · NCT07005336 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2026 (2)
Phase 2Intrahepatic Cholangiocarcinoma (Icc), Gall Bladder CancerRecruiting
Est. primary completion 2026-09-01 · NCT06852287 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Stage III Lung Cancer AJCC v8, Stage III Lung Non-Small Cell Cancer AJCC v7, Stage IIIA Lung Cancer AJCC v8 …Recruiting
Est. primary completion 2026-09-30 · NCT04892953 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2026 (4)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2026-12 · NCT06202261 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2026-12 · NCT06623656 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast CarcinomaRecruiting
Est. primary completion 2026-12-30 · NCT03606967 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Intrahepatic Cholangiocarcinoma (Icc)Recruiting
Est. primary completion 2026-12-31 · NCT06721286 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2027 (12)
January 2027 (1)
Phase 3Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma, Lung Non-Squamous Non-Small Cell Carcinoma …Recruiting
Est. primary completion 2027-01-31 · NCT04267848 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

February 2027 (1)
Phase 2Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast CarcinomaRecruiting
Est. primary completion 2027-02-12 · NCT06492759 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

April 2027 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-04 · NCT06409390 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

May 2027 (1)
Phase 2Lung CancerRecruiting
Est. primary completion 2027-05-30 · NCT06421298 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

June 2027 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-06 · NCT06922591 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

July 2027 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-07-24 · NCT07088263 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

August 2027 (1)
Phase 2Metastatic Triple-Negative Breast CancerActive not recruiting
Est. primary completion 2027-08 · NCT06027268 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2027 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-09 · NCT05592626 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2027 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-10-31 · NCT06026657 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2027 (3)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-12 · NCT05431270 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-12 · NCT07007559 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-12-31 · NCT05601440 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2028 (11)
January 2028 (1)
Phase 2/3HER2-positive Breast Cancer, Metastatic Breast CancerNot yet recruiting
Est. primary completion 2028-01-16 · NCT07366840 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

April 2028 (1)
Phase 3Metastatic HER2-positive Breast CancerRecruiting
Est. primary completion 2028-04-28 · NCT06435429 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

May 2028 (1)
Phase 2Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2028-05 · NCT07418931 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

June 2028 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-06 · NCT05786924 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

July 2028 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-07 · NCT07158489 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

August 2028 (3)
Phase 2Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast CancersActive not recruiting
Est. primary completion 2028-08 · NCT06449222 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-08-01 · NCT05800587 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Solid TumorsRecruiting
Est. primary completion 2028-08-15 · NCT07492680 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2028 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-09 · NCT07020065 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2028 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-10-13 · NCT07223047 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2028 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-12 · NCT07020221 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2029 (4)
April 2029 (1)
Phase 3Resectable Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8Recruiting
Est. primary completion 2029-04-30 · NCT06632327 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2029 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2029-09 · NCT07563738 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2029 (2)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-12 · NCT07173751 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 1/2Intrahepatic Cholangiocarcinoma (Icc)Recruiting
Est. primary completion 2029-12-31 · NCT07632235 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2030 (3)
June 2030 (1)
Phase 2/3Locally Advanced Triple-negative Breast Cancer, Metastatic Triple-negative Breast CancerRecruiting
Est. primary completion 2030-06 · NCT07544056 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2030 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-09-30 · NCT03424005 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2030 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2030-12-31 · NCT07050043 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2032 (2)
February 2032 (1)
Phase 2Lung Neoplasm MalignantRecruiting
Est. primary completion 2032-02-06 · NCT06788912 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

April 2032 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2032-04-30 · NCT05981001 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2033 (2)
May 2033 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2033-05-16 · NCT06623422 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

July 2033 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2033-07 · NCT04198766 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2034 (1)
June 2034 (1)
Phase 2Triple Negative Breast Cancer, Metastatic Triple-negative Breast CancerNot yet recruiting
Est. primary completion 2034-06-01 · NCT07528768 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

See the full readout calendar ↗

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Competitive landscape

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