Phase 3 Mesothelioma Trial, Terminated NCT01907100 Sponsor: Boehringer Ingelheim Condition: Mesothelioma
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 545 participants across two phases. In Phase II, 43 people were assigned to placebo and 44 to nintedanib. In Phase III, 229 people were assigned to each group. The trial was looking at nintedanib (a type of cancer medicine) added to standard chemotherapy, compared to chemotherapy plus a placebo (an inactive treatment), in people with a type of lung cancer. The main thing being measured was how long people lived without their cancer getting worse — called "progression-free survival" — and a key secondary measure was how long people lived overall. The reported data shows that in the Phase II part of the trial, the placebo group had a median progression-free survival (meaning half the group reached this point) of 5.72 months, while the nintedanib group had 9.36 months. In the larger Phase III part, the reported figures were 6.97 months for placebo and 6.77 months for nintedanib. For overall survival — how long people lived from the start of the trial — the Phase II results showed 14.46 months for placebo and 18.30 months for nintedanib, while Phase III showed 16.07 months for placebo and 14.36 months for nintedanib. These numbers represent the midpoint (median) for each group, meaning half the participants in each group lived longer than this and half did not reach it. For the Phase III part only, the reported data also shows that about 42.8% of people in the placebo group and 45.0% in the nintedanib group had their tumour shrink by a meaningful amount (called an "objective response"). Additionally, 92.6% of the placebo group and 90.8% of the nintedanib group had their disease either shrink or stay stable for at least 36 days (called "disease control"). These numbers describe what was observed and recorded in the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Mesothelioma Trial, Terminated

NCT01907100
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with a type of cancer called malignant pleural mesothelioma (MPM), confirmed by a tissue sample, and your specific subtype is either "epithelioid" or "biphasic" (or only "epithelioid" depending on which part of the trial you would join)
  • Your doctor believes you are likely to live for at least 3 more months
  • You are in relatively good physical condition, able to carry out normal daily activities with little or no difficulty (measured by a standard health scale called ECOG, scoring 0 or 1)
  • Your cancer can be measured using medical scans, according to specific measurement guidelines used in this trial

Who may not be able to join:

  • You have previously had chemotherapy treatment for your mesothelioma
  • You have previously been treated with a drug called nintedanib, or have received any other prior cancer treatment
  • Your mesothelioma is of the "sarcomatoid" subtype, or in some cases the "biphasic" subtype (confirm with trial site for which part of the trial applies to you)
  • You are experiencing troublesome nerve problems, such as pain, numbness, or weakness (symptomatic neuropathy)
  • You have had radiotherapy (other than to the arms or legs) within the 3 months before your first scans for this trial
  • You have cancer that has spread to your brain and has not been stable for at least 4 weeks
  • Your scans show that your tumour has hollow or dead areas inside it, or that the cancer is growing into major blood vessels
  • You have significant heart or blood vessel problems
  • Your blood tests show that your blood, kidneys, or liver are not working well enough (confirm specific levels with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Boehringer Ingelheim, Boehringer Ingelheim

Australian sites

Northern Cancer Institute, St Leonards, New South Wales
Calvary Mater Newcastle Hospital, Waratah, New South Wales
The Prince Charles Hospital, Chermside, Queensland
Mater Cancer Care Centre, South Brisbane, Queensland
Box Hill Hospital, Box Hill, Victoria
Peninsula Haematology & Oncology, Frankston, Victoria
Austin Health, Heidelberg, Victoria
Border Onclogy Research, Wodonga, Victoria
Sir Charles Gairdner Hospital, Nedlands, Western Australia
Perth Oncology, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
19 September 2013
Est. completion
16 March 2018

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇨🇱 Chile 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇬 Egypt 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇿🇦 South Africa 🇪🇸 Spain 🇸🇪 Sweden Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

10 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression-Free Survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov